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S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Sponsor
Southwest Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02562716
Collaborator
National Cancer Institute (NCI) (NIH)
147
Enrollment
807
Locations
2
Arms
80.8
Anticipated Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fluorouracil
  • Drug: Gemcitabine Hydrochloride
  • Drug: Irinotecan Hydrochloride
  • Drug: Oxaliplatin
  • Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
  • Procedure: Pancreatectomy
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:

  1. To assess 2-year overall survival in each treatment arm (fluorouracil, irinotecan hydrochloride, and oxaliplatin [modified (m)FOLFIRINOX] and gemcitabine [gemcitabine hydrochloride]/nab-paclitaxel [paclitaxel albumin-stabilized nanoparticle formulation]) in patients with resectable pancreatic cancer.

  2. If the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall survival.

SECONDARY OBJECTIVES:

  1. To estimate, for all patients and within treatment arms: frequency and severity of adverse events associated with chemotherapy in the perioperative setting.

  2. To estimate, for all patients and within treatment arms: proportion of patients going to surgery for resection after preoperative chemotherapy.

  3. To estimate, for all patients and within treatment arms: proportion of patients achieving macroscopically complete tumor removal with negative microscopic surgical margins (R0) resection after preoperative chemotherapy.

  4. To estimate, for all patients and within treatment arms: overall response rate following preoperative chemotherapy, including confirmed and unconfirmed, complete and partial response, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  5. To estimate, for all patients and within treatment arms: pathologic response rates after R0 or macroscopically complete tumor removal with any positive microscopic surgical margin (R1) resection.

  6. To estimate, for all patients and within treatment arms: patterns of recurrence (loco-regional, distant) after R0 or R1 resection.

  7. To estimate, for all patients and within treatment arms: disease-free survival from the time of R0 or R1 resection.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma
Actual Study Start Date :
Jan 6, 2016
Actual Primary Completion Date :
May 31, 2020
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (mFOLFIRINOX, surgery)

Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.

Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757

    • Drug: Irinotecan Hydrochloride
    Given IV
    Other Names:
  • Campto
  • Camptosar
  • Camptothecin 11
  • Camptothecin-11
  • CPT 11
  • CPT-11
  • Irinomedac
  • U-101440E

    • Drug: Oxaliplatin
    Given IV
    Other Names:
  • 1-OHP
  • Ai Heng
  • Aiheng
  • Dacotin
  • Dacplat
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatin
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669

    • Procedure: Pancreatectomy
    Undergo pancreatectomy
    Other Names:
  • Excision of the Pancreas
  • Pancreas Excision

    		•
    Experimental: Arm II (gemcitabine, nab-paclitaxel, and surgery)

    Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.

    Drug: Gemcitabine Hydrochloride
    Given IV
    Other Names:
  • dFdCyd
  • Difluorodeoxycytidine Hydrochloride
  • Gemzar
  • LY-188011

    • Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
    Given IV
    Other Names:
  • ABI 007
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • Albumin-Stabilized Nanoparticle Paclitaxel
  • nab-paclitaxel
  • Nanoparticle Albumin-bound Paclitaxel
  • Nanoparticle Paclitaxel
  • protein-bound paclitaxel

    • Procedure: Pancreatectomy
    Undergo pancreatectomy
    Other Names:
  • Excision of the Pancreas
  • Pancreas Excision

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm.]

      OS is the length of time between protocol registration and patient death

    Secondary Outcome Measures

    1. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [Duration of treatment and follow up until death or 4 years post registration.]

      Only adverse events that are possibly, probably or definitely related to preoperative and postoperative chemotherapy are reported.

    2. Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy. [Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).]

    3. Number of Patients Achieving R0 Resection After Preoperative Chemotherapy. [Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).]

      R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins).

    4. Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1. [Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).]

      Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    5. Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. [Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).]

      Pathologic response was evaluated after the patient had surgery, and was based on local pathology review of the resected surgical specimen, according to the following Tumor Regression Grade definitions: 0: Complete response - no residual tumor Moderate response - minimal residual cancer (single cells or small groups of cancer cells) Minimal response - residual cancer outgrown by fibrosis Poor or no response - no definite response identified (minimal or no tumor kill; extensive residual cancer)

    6. Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. [Up to 4 years]

      Loco-regional recurrence is defined as any evidence of new disease within the pancreatic tumor bed based on surveillance scans. The pancreatic tumor bed includes: Superior mesenteric artery and vein lymph nodes Lymph nodes in porta hepatis (bile duct, portal vein, hepatic artery lymph nodes) Lymph nodes around left renal vein, inferior vena cava or aorta Celiac axis lymph nodes. Distant Recurrence is defined as any evidence of new disease outside the primary tumor bed (liver, lungs, etc.) based on surveillance scans.

    7. Disease-free Survival From the Time of R0 or R1 Resection. [Up to 4 years]

      Disease-free survival (DFS) is calculated for patients who undergo surgical resection (R0/R1). DFS will be measured from the date of surgical resection to date of first documentation of recurrence (loco-regional or distant) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have histologically or cytologically proven pancreatic adenocarcinoma; histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible

    • Patients must have measurable disease in the pancreas; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form

    • Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography [PET]/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis, where resectable is defined as:

    • No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery)

    • No involvement, or < 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence

    • No evidence of metastatic disease

    • Note: for tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease

    • CT scans or MRIs used to assess disease at baseline must be submitted for central review

    • Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration

    • Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer

    • Patients must have a Zubrod performance status of 0-1

    • Absolute neutrophil count (ANC) >= 1,500/mcL

    • Platelets >= 100,000/mcL

    • Hemoglobin >= 9 g/dL

    • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)

    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN

    • Serum albumin >= 3 g/dL

    • Serum creatinine =< IULN within 14 days prior to registration

    • Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will NOT be eligible

    • No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or other cancer for which the patient has been disease and treatment-free for two years

    • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method for up to 3 months after the final administered dose of chemotherapy; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures

    • Sites must seek additional patient consent for the future use of specimens

    • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

    • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36688
    3 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    4 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
    5 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    6 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    7 Alaska Regional Hospital Anchorage Alaska United States 99508
    8 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    9 Anchorage Oncology Centre Anchorage Alaska United States 99508
    10 Katmai Oncology Group Anchorage Alaska United States 99508
    11 Providence Alaska Medical Center Anchorage Alaska United States 99508
    12 University of Arizona Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
    13 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
    14 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    15 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    16 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    17 Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas United States 72401
    18 Kaiser Permanente-Anaheim Anaheim California United States 92806
    19 Kaiser Permanente-Deer Valley Medical Center Antioch California United States 94531
    20 Sutter Auburn Faith Hospital Auburn California United States 95602
    21 Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California United States 95603
    22 Kaiser Permanente-Baldwin Park Baldwin Park California United States 91706
    23 Kaiser Permanente-Bellflower Bellflower California United States 90706
    24 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    25 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    26 Mills-Peninsula Medical Center Burlingame California United States 94010
    27 Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California United States 95682
    28 Eden Hospital Medical Center Castro Valley California United States 94546
    29 Sutter Davis Hospital Davis California United States 95616
    30 Epic Care-Dublin Dublin California United States 94568
    31 Bay Area Breast Surgeons Inc Emeryville California United States 94608
    32 Epic Care Partners in Cancer Care Emeryville California United States 94608
    33 Kaiser Permanente-Fontana Fontana California United States 92335
    34 Kaiser Permanente-Fremont Fremont California United States 94538
    35 Palo Alto Medical Foundation-Fremont Fremont California United States 94538
    36 Kaiser Permanente-Fresno Fresno California United States 93720
    37 Kaiser Permanente - Harbor City Harbor City California United States 90710
    38 Kaiser Permanente-Irvine Irvine California United States 92618
    39 UC San Diego Moores Cancer Center La Jolla California United States 92093
    40 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    41 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    42 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    43 Kaiser Permanente-Cadillac Los Angeles California United States 90034
    44 Contra Costa Regional Medical Center Martinez California United States 94553-3156
    45 Memorial Medical Center Modesto California United States 95355
    46 Kaiser Permanente-Modesto Modesto California United States 95356
    47 Palo Alto Medical Foundation-Camino Division Mountain View California United States 94040
    48 Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California United States 94040
    49 USC Norris Oncology/Hematology-Newport Beach Newport Beach California United States 92663
    50 Sutter Cancer Research Consortium Novato California United States 94945
    51 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
    52 Bay Area Tumor Institute Oakland California United States 94609
    53 Kaiser Permanente-Oakland Oakland California United States 94611
    54 Saint Joseph Hospital - Orange Orange California United States 92868
    55 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    56 Palo Alto Medical Foundation Health Care Palo Alto California United States 94301
    57 Kaiser Permanente - Panorama City Panorama City California United States 91402
    58 Keck Medical Center of USC Pasadena Pasadena California United States 91105
    59 Kaiser Permanente-Redwood City Redwood City California United States 94063
    60 Kaiser Permanente-Richmond Richmond California United States 94801
    61 Kaiser Permanente-Riverside Riverside California United States 92505
    62 Kaiser Permanente-Roseville Roseville California United States 95661
    63 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
    64 Sutter Roseville Medical Center Roseville California United States 95661
    65 Sutter Medical Center Sacramento Sacramento California United States 95816
    66 Kaiser Permanente-South Sacramento Sacramento California United States 95823
    67 Kaiser Permanente - Sacramento Sacramento California United States 95825
    68 University of California San Diego San Diego California United States 92103
    69 Kaiser Permanente-San Diego Mission San Diego California United States 92108
    70 Kaiser Permanente-San Diego Zion San Diego California United States 92120
    71 California Pacific Medical Center-Pacific Campus San Francisco California United States 94115
    72 Kaiser Permanente-San Francisco San Francisco California United States 94115
    73 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
    74 Kaiser Permanente San Leandro San Leandro California United States 94577
    75 Kaiser Permanente-San Marcos San Marcos California United States 92078
    76 Kaiser Permanente-San Rafael San Rafael California United States 94903
    77 Kaiser San Rafael-Gallinas San Rafael California United States 94903
    78 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
    79 Palo Alto Medical Foundation-Santa Cruz Santa Cruz California United States 95065
    80 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
    81 Sutter Pacific Medical Foundation Santa Rosa California United States 95403
    82 Kaiser Permanente-South San Francisco South San Francisco California United States 94080
    83 Kaiser Permanente-Stockton Stockton California United States 95210
    84 Palo Alto Medical Foundation-Sunnyvale Sunnyvale California United States 94086
    85 Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California United States 95687
    86 Kaiser Permanente Medical Center-Vacaville Vacaville California United States 95688
    87 Kaiser Permanente-Vallejo Vallejo California United States 94589
    88 Sutter Solano Medical Center/Cancer Center Vallejo California United States 94589
    89 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    90 Kaiser Permanente-Woodland Hills Woodland Hills California United States 91367
    91 University of Colorado Hospital Aurora Colorado United States 80045
    92 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    93 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    94 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    95 Porter Adventist Hospital Denver Colorado United States 80210
    96 Mercy Medical Center Durango Colorado United States 81301
    97 Southwest Oncology PC Durango Colorado United States 81301
    98 Poudre Valley Hospital Fort Collins Colorado United States 80524
    99 Mountain Blue Cancer Care Center Golden Colorado United States 80401
    100 Grand Valley Oncology Grand Junction Colorado United States 81505
    101 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
    102 Saint Anthony Hospital Lakewood Colorado United States 80228
    103 Littleton Adventist Hospital Littleton Colorado United States 80122
    104 Longmont United Hospital Longmont Colorado United States 80501
    105 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    106 Parker Adventist Hospital Parker Colorado United States 80138
    107 Rocky Mountain Cancer Centers-Parker Parker Colorado United States 80138
    108 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    109 Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado United States 81008
    110 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
    111 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    112 Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut United States 06516
    113 Beebe Medical Center Lewes Delaware United States 19958
    114 Christiana Gynecologic Oncology LLC Newark Delaware United States 19713
    115 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    116 Helen F Graham Cancer Center Newark Delaware United States 19713
    117 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    118 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    119 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    120 Nanticoke Memorial Hospital Seaford Delaware United States 19973
    121 Christiana Care Health System-Wilmington Hospital Wilmington Delaware United States 19801
    122 UM Sylvester Comprehensive Cancer Center at Coral Springs Coral Springs Florida United States 33065
    123 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
    124 Regional Cancer Center-Lee Memorial Health System Fort Myers Florida United States 33905
    125 UM Sylvester Comprehensive Cancer Center at Hollywood Hollywood Florida United States 33021
    126 The Watson Clinic Lakeland Florida United States 33805
    127 Jackson Memorial Hospital-Holtz Children's Hospital Miami Florida United States 33136
    128 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    129 UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida United States 33176
    130 UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida United States 33324
    131 Cleveland Clinic-Weston Weston Florida United States 33331
    132 Grady Health System Atlanta Georgia United States 30303
    133 Emory University Hospital Midtown Atlanta Georgia United States 30308
    134 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    135 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    136 Hawaii Oncology Inc-Pali Momi 'Aiea Hawaii United States 96701
    137 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    138 The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii United States 96701
    139 Hawaii Cancer Care Inc-POB II Honolulu Hawaii United States 96813
    140 Hawaii Oncology Inc-POB I Honolulu Hawaii United States 96813
    141 Island Urology Honolulu Hawaii United States 96813
    142 Queen's Medical Center Honolulu Hawaii United States 96813
    143 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    144 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    145 Hawaii Cancer Care Inc-Liliha Honolulu Hawaii United States 96817
    146 Hawaii Oncology Inc-Kuakini Honolulu Hawaii United States 96817
    147 Kuakini Medical Center Honolulu Hawaii United States 96817
    148 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    149 Kaiser Permanente Moanalua Medical Center Honolulu Hawaii United States 96819
    150 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    151 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    152 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    153 Saint Luke's Mountain States Tumor Institute Boise Idaho United States 83712
    154 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    155 Kootenai Medical Center Coeur d'Alene Idaho United States 83814
    156 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    157 Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland Idaho United States 83619
    158 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    159 Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho United States 83642
    160 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    161 Saint Luke's Mountain States Tumor Institute - Nampa Nampa Idaho United States 83686
    162 Kootenai Cancer Center Post Falls Idaho United States 83854
    163 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    164 Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls Idaho United States 83301
    165 Rush - Copley Medical Center Aurora Illinois United States 60504
    166 Saint Joseph Medical Center Bloomington Illinois United States 61701
    167 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    168 Illinois CancerCare-Canton Canton Illinois United States 61520
    169 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    170 SIH Cancer Institute Carterville Illinois United States 62918
    171 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    172 Centralia Oncology Clinic Centralia Illinois United States 62801
    173 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    174 Carle on Vermilion Danville Illinois United States 61832
    175 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    176 Decatur Memorial Hospital Decatur Illinois United States 62526
    177 Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois United States 60115
    178 Carle Physician Group-Effingham Effingham Illinois United States 62401
    179 Crossroads Cancer Center Effingham Illinois United States 62401
    180 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    181 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    182 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    183 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    184 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    185 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    186 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    187 Garneau, Stewart C MD (UIA Investigator) Moline Illinois United States 61265
    188 Spector, David MD (UIA Investigator) Moline Illinois United States 61265
    189 Trinity Medical Center Moline Illinois United States 61265
    190 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    191 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
    192 University of Chicago Medicine-Orland Park Orland Park Illinois United States 60462
    193 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    194 Radiation Oncology of Northern Illinois Ottawa Illinois United States 61350
    195 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    196 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    197 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    198 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
    199 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    200 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    201 Illinois CancerCare-Peru Peru Illinois United States 61354
    202 Valley Radiation Oncology Peru Illinois United States 61354
    203 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    204 Central Illinois Hematology Oncology Center Springfield Illinois United States 62702
    205 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    206 Springfield Clinic Springfield Illinois United States 62702
    207 Memorial Medical Center Springfield Illinois United States 62781
    208 Cancer Care Specialists of Illinois-Swansea Swansea Illinois United States 62226
    209 Southwest Illinois Health Services LLP Swansea Illinois United States 62226
    210 Carle Cancer Center Urbana Illinois United States 61801
    211 The Carle Foundation Hospital Urbana Illinois United States 61801
    212 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    213 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
    214 Deaconess Clinic Downtown Evansville Indiana United States 47713
    215 Radiation Oncology Associates PC Fort Wayne Indiana United States 46804
    216 Parkview Hospital Randallia Fort Wayne Indiana United States 46805
    217 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    218 Sidney and Lois Eskenazi Hospital Indianapolis Indiana United States 46202
    219 Franciscan Saint Anthony Health-Michigan City Michigan City Indiana United States 46360
    220 Woodland Cancer Care Center Michigan City Indiana United States 46360
    221 Chancellor Center for Oncology Newburgh Indiana United States 47630
    222 Reid Health Richmond Indiana United States 47374
    223 Mary Greeley Medical Center Ames Iowa United States 50010
    224 McFarland Clinic PC - Ames Ames Iowa United States 50010
    225 Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa United States 52722
    226 McFarland Clinic PC-Boone Boone Iowa United States 50036
    227 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    228 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    229 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
    230 Greater Regional Medical Center Creston Iowa United States 50801
    231 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    232 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    233 Broadlawns Medical Center Des Moines Iowa United States 50314
    234 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    235 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    236 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    237 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
    238 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
    239 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
    240 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    241 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    242 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    243 Coffeyville Regional Medical Center Coffeyville Kansas United States 67337
    244 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    245 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    246 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    247 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    248 Saint Catherine Hospital Garden City Kansas United States 67846
    249 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    250 Saint Rose Ambulatory and Surgery Center Great Bend Kansas United States 67530
    251 Hays Medical Center Hays Kansas United States 67601
    252 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    253 University of Kansas Cancer Center-West Kansas City Kansas United States 66112
    254 University of Kansas Cancer Center Kansas City Kansas United States 66160
    255 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    256 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    257 Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas United States 66219
    258 Minimally Invasive Surgery Hospital Lenexa Kansas United States 66219
    259 Cancer Center of Kansas-Liberal Liberal Kansas United States 67905
    260 Cancer Center of Kansas-Manhattan Manhattan Kansas United States 66502
    261 Cancer Center of Kansas - McPherson McPherson Kansas United States 67460
    262 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    263 Olathe Medical Center Olathe Kansas United States 66061
    264 Menorah Medical Center Overland Park Kansas United States 66209
    265 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    266 Saint Luke's South Hospital Overland Park Kansas United States 66213
    267 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    268 Via Christi Hospital-Pittsburg Pittsburg Kansas United States 66762
    269 Kansas City NCI Community Oncology Research Program Prairie Village Kansas United States 66208
    270 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    271 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    272 Salina Regional Health Center Salina Kansas United States 67401
    273 Saint Francis Hospital and Medical Center - Topeka Topeka Kansas United States 66606
    274 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    275 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    276 Associates In Womens Health Wichita Kansas United States 67208
    277 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    278 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    279 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    280 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    281 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    282 Baptist Health Corbin Corbin Kentucky United States 40701
    283 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
    284 Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky United States 41017
    285 Hardin Memorial Hospital Elizabethtown Kentucky United States 42701
    286 Baptist Health Lexington Lexington Kentucky United States 40503
    287 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    288 Saint Joseph Hospital East Lexington Kentucky United States 40509
    289 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    290 Saint Joseph London London Kentucky United States 40741
    291 Jewish Hospital Louisville Kentucky United States 40202
    292 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    293 Baptist Health Louisville Louisville Kentucky United States 40207
    294 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
    295 Jewish Hospital Medical Center Northeast Louisville Kentucky United States 40245
    296 Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville Kentucky United States 42431
    297 Baptist Health Paducah Paducah Kentucky United States 42003
    298 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
    299 Ochsner Health Center-Summa Baton Rouge Louisiana United States 70809
    300 Medical Center of Baton Rouge Baton Rouge Louisiana United States 70816
    301 Ochsner Medical Center Kenner Kenner Louisiana United States 70065
    302 University Health-Conway Monroe Louisiana United States 71202
    303 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    304 University Medical Center New Orleans New Orleans Louisiana United States 70112
    305 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    306 Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana United States 71103
    307 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
    308 Lafayette Family Cancer Center-EMMC Brewer Maine United States 04412
    309 Penobscot Bay Medical Center Rockport Maine United States 04856
    310 Frederick Memorial Hospital Frederick Maryland United States 21701
    311 Boston Medical Center Boston Massachusetts United States 02118
    312 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    313 Baystate Medical Center Springfield Massachusetts United States 01199
    314 Winchester Hospital Winchester Massachusetts United States 01890
    315 Hickman Cancer Center Adrian Michigan United States 49221
    316 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    317 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    318 Bronson Battle Creek Battle Creek Michigan United States 49017
    319 IHA Hematology Oncology Consultants-Brighton Brighton Michigan United States 48114
    320 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    321 IHA Hematology Oncology Consultants-Canton Canton Michigan United States 48188
    322 Saint Joseph Mercy Canton Canton Michigan United States 48188
    323 Caro Cancer Center Caro Michigan United States 48723
    324 IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan United States 48118
    325 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    326 Hematology Oncology Consultants-Clarkston Clarkston Michigan United States 48346
    327 Newland Medical Associates-Clarkston Clarkston Michigan United States 48346
    328 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    329 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    330 Ascension Saint John Hospital Detroit Michigan United States 48236
    331 Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan United States 48054
    332 Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    333 Beaumont Hospital - Farmington Hills Farmington Hills Michigan United States 48336
    334 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
    335 Genesee Hematology Oncology PC Flint Michigan United States 48503
    336 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    337 Hurley Medical Center Flint Michigan United States 48503
    338 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    339 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    340 Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan United States 48236
    341 Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236
    342 Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan United States 48236
    343 William Beaumont Hospital-Grosse Point Grosse Pointe Michigan United States 48230
    344 Allegiance Health Jackson Michigan United States 49201
    345 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    346 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    347 Borgess Medical Center Kalamazoo Michigan United States 49048
    348 Sparrow Hospital Lansing Michigan United States 48912
    349 Hope Cancer Clinic Livonia Michigan United States 48154
    350 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    351 Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan United States 48044
    352 Michigan Breast Specialists-Macomb Township Macomb Michigan United States 48044
    353 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan United States 48453
    354 Monroe Cancer Center Monroe Michigan United States 48162
    355 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
    356 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    357 Lakeland Hospital Niles Niles Michigan United States 49120
    358 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
    359 Hope Cancer Center Pontiac Michigan United States 48341
    360 Newland Medical Associates-Pontiac Pontiac Michigan United States 48341
    361 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    362 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    363 Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan United States 48309
    364 Michigan Cancer Specialists Roseville Michigan United States 48066
    365 Oakland Colon and Rectal Association Royal Oak Michigan United States 48067
    366 Cancer Care Associates PC Royal Oak Michigan United States 48073
    367 Comprehensive Medical Center PLLC Royal Oak Michigan United States 48073
    368 Hematology Oncology Consultants PC Royal Oak Michigan United States 48073
    369 Oakland Medical Group Royal Oak Michigan United States 48073
    370 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    371 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    372 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    373 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    374 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    375 Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan United States 48312
    376 Premier Hematology Oncology Care Sterling Heights Michigan United States 48312
    377 Mitchell Folbe MD PC Sterling Heights Michigan United States 48314
    378 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
    379 Munson Medical Center Traverse City Michigan United States 49684
    380 Michigan Institute of Urology-Town Center Troy Michigan United States 48084
    381 Claudia BR Herke MD PC Troy Michigan United States 48085
    382 William Beaumont Hospital - Troy Troy Michigan United States 48085
    383 Hematology Oncology Consultants PC-Troy Troy Michigan United States 48098
    384 Advanced Breast Care Center PLLC Warren Michigan United States 48088
    385 Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan United States 48093
    386 Macomb Hematology Oncology PC Warren Michigan United States 48093
    387 Michigan Breast Specialists-Warren Warren Michigan United States 48093
    388 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    389 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
    390 Metro Health Hospital Wyoming Michigan United States 49519
    391 Huron Gastroenterology PC Ypsilanti Michigan United States 48106
    392 IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan United States 48197
    393 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    394 Essentia Health Saint Joseph's Medical Center Brainerd Minnesota United States 56401
    395 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    396 Mercy Hospital Coon Rapids Minnesota United States 55433
    397 Essentia Health Cancer Center Duluth Minnesota United States 55805
    398 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
    399 Miller-Dwan Hospital Duluth Minnesota United States 55805
    400 Fairview-Southdale Hospital Edina Minnesota United States 55435
    401 Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota United States 56537
    402 Unity Hospital Fridley Minnesota United States 55432
    403 Essentia Health Hibbing Clinic Hibbing Minnesota United States 55746
    404 Fairview Maple Grove Medical Center Maple Grove Minnesota United States 55369
    405 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    406 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    407 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    408 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    409 Health Partners Inc Minneapolis Minnesota United States 55454
    410 New Ulm Medical Center New Ulm Minnesota United States 56073
    411 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    412 Mayo Clinic Rochester Minnesota United States 55905
    413 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    414 Regions Hospital Saint Paul Minnesota United States 55101
    415 United Hospital Saint Paul Minnesota United States 55102
    416 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    417 Lakeview Hospital Stillwater Minnesota United States 55082
    418 Essentia Health Virginia Clinic Virginia Minnesota United States 55792
    419 Ridgeview Medical Center Waconia Minnesota United States 55387
    420 Rice Memorial Hospital Willmar Minnesota United States 56201
    421 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    422 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    423 Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi United States 39705
    424 Baptist Cancer Center-Grenada Grenada Mississippi United States 38901
    425 Hattiesburg Clinic - Hematology/Oncology Clinic Hattiesburg Mississippi United States 39401
    426 Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi United States 38652
    427 Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi United States 38655
    428 Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi United States 38671
    429 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    430 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    431 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
    432 Cox Cancer Center Branson Branson Missouri United States 65616
    433 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    434 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    435 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
    436 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    437 Centerpoint Medical Center LLC Independence Missouri United States 64057
    438 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    439 Freeman Health System Joplin Missouri United States 64804
    440 Mercy Hospital Joplin Joplin Missouri United States 64804
    441 Truman Medical Center Kansas City Missouri United States 64108
    442 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    443 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
    444 Kansas City Veterans Affairs Medical Center Kansas City Missouri United States 64128
    445 The University of Kansas Cancer Center-South Kansas City Missouri United States 64131
    446 Research Medical Center Kansas City Missouri United States 64132
    447 The University of Kansas Cancer Center-North Kansas City Missouri United States 64154
    448 The University of Kansas Cancer Center-Lee's Summit Lee's Summit Missouri United States 64064
    449 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    450 Liberty Radiation Oncology Center Liberty Missouri United States 64068
    451 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    452 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    453 Heartland Regional Medical Center Saint Joseph Missouri United States 64507
    454 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    455 Washington University School of Medicine Saint Louis Missouri United States 63110
    456 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    457 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    458 Siteman Cancer Center at Christian Hospital Saint Louis Missouri United States 63136
    459 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    460 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    461 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    462 Mercy Hospital Springfield Springfield Missouri United States 65804
    463 CoxHealth South Hospital Springfield Missouri United States 65807
    464 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    465 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    466 Mercy Hospital Washington Washington Missouri United States 63090
    467 Billings Clinic Cancer Center Billings Montana United States 59101
    468 Saint Vincent Healthcare Billings Montana United States 59101
    469 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    470 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    471 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    472 Saint Peter's Community Hospital Helena Montana United States 59601
    473 Kalispell Regional Medical Center Kalispell Montana United States 59901
    474 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    475 Community Medical Hospital Missoula Montana United States 59804
    476 CHI Health Saint Francis Grand Island Nebraska United States 68803
    477 Heartland Hematology and Oncology Kearney Nebraska United States 68845
    478 CHI Health Good Samaritan Kearney Nebraska United States 68847
    479 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
    480 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    481 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    482 Hematology and Oncology Consultants PC Omaha Nebraska United States 68122
    483 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    484 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    485 Creighton University Medical Center Omaha Nebraska United States 68131
    486 University of Nebraska Medical Center Omaha Nebraska United States 68198
    487 Midlands Community Hospital Papillion Nebraska United States 68046
    488 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    489 Norris Cotton Cancer Center-Manchester Manchester New Hampshire United States 03102
    490 Norris Cotton Cancer Center-Nashua Nashua New Hampshire United States 03063
    491 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
    492 Inspira Medical Center Woodbury Woodbury New Jersey United States 08096
    493 Lovelace Medical Center-Saint Joseph Square Albuquerque New Mexico United States 87102
    494 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    495 Memorial Medical Center - Las Cruces Las Cruces New Mexico United States 88011
    496 Hematology Oncology Associates of Central New York-Auburn Auburn New York United States 13021
    497 Montefiore Medical Center-Einstein Campus Bronx New York United States 10461
    498 Montefiore Medical Center-Weiler Hospital Bronx New York United States 10461
    499 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    500 Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York United States 13057
    501 Glens Falls Hospital Glens Falls New York United States 12801
    502 Orange Regional Medical Center Middletown New York United States 10940
    503 NYU Winthrop Hospital Mineola New York United States 11501
    504 Vassar Brothers Medical Center Poughkeepsie New York United States 12601
    505 University of Rochester Rochester New York United States 14642
    506 State University of New York Upstate Medical University Syracuse New York United States 13210
    507 Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York United States 13215
    508 Randolph Hospital Asheboro North Carolina United States 27203
    509 AdventHealth Infusion Center Asheville Asheville North Carolina United States 28803
    510 Cone Health Cancer Center at Alamance Regional Burlington North Carolina United States 27215
    511 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    512 Duke University Medical Center Durham North Carolina United States 27710
    513 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    514 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    515 Cone Health Cancer Center Greensboro North Carolina United States 27403
    516 AdventHealth Hendersonville Hendersonville North Carolina United States 28792
    517 Onslow Memorial Hospital Jacksonville North Carolina United States 28546
    518 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    519 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    520 Cape Fear Cancer Specialists-Leland Leland North Carolina United States 28451
    521 Cone Heath Cancer Center at Mebane Mebane North Carolina United States 27302
    522 Annie Penn Memorial Hospital Reidsville North Carolina United States 27320
    523 Cape Fear Cancer Specialists Wilmington North Carolina United States 28401
    524 New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina United States 28401
    525 Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina United States 27104
    526 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    527 Essentia Health Cancer Center-South University Clinic Fargo North Dakota United States 58103
    528 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    529 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    530 Cleveland Clinic Akron General Akron Ohio United States 44307
    531 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    532 Indu and Raj Soin Medical Center Beavercreek Ohio United States 45431
    533 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    534 Dayton Physicians LLC-Miami Valley South Centerville Ohio United States 45459
    535 Miami Valley Hospital South Centerville Ohio United States 45459
    536 Geauga Hospital Chardon Ohio United States 44024
    537 Adena Regional Medical Center Chillicothe Ohio United States 45601
    538 Oncology Hematology Care Inc-Eden Park Cincinnati Ohio United States 45202
    539 Oncology Hematology Care Inc-Mercy West Cincinnati Ohio United States 45211
    540 University of Cincinnati/Barrett Cancer Center Cincinnati Ohio United States 45219
    541 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    542 Oncology Hematology Care Inc - Anderson Cincinnati Ohio United States 45230
    543 Oncology Hematology Care Inc-Kenwood Cincinnati Ohio United States 45236
    544 Bethesda North Hospital Cincinnati Ohio United States 45242
    545 Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio United States 45242
    546 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
    547 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
    548 Case Western Reserve University Cleveland Ohio United States 44106
    549 MetroHealth Medical Center Cleveland Ohio United States 44109
    550 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    551 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    552 Mount Carmel East Hospital Columbus Ohio United States 43213
    553 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    554 Riverside Methodist Hospital Columbus Ohio United States 43214
    555 Grant Medical Center Columbus Ohio United States 43215
    556 The Mark H Zangmeister Center Columbus Ohio United States 43219
    557 Mount Carmel Health Center West Columbus Ohio United States 43222
    558 Doctors Hospital Columbus Ohio United States 43228
    559 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    560 Miami Valley Hospital Dayton Ohio United States 45409
    561 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    562 Miami Valley Hospital North Dayton Ohio United States 45415
    563 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
    564 Delaware Radiation Oncology Delaware Ohio United States 43015
    565 Grady Memorial Hospital Delaware Ohio United States 43015
    566 Mercy Cancer Center-Elyria Elyria Ohio United States 44035
    567 Oncology Hematology Care Inc-Healthplex Fairfield Ohio United States 45014
    568 Armes Family Cancer Center Findlay Ohio United States 45840
    569 Blanchard Valley Hospital Findlay Ohio United States 45840
    570 Orion Cancer Care Findlay Ohio United States 45840
    571 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    572 Dayton Physicians LLC-Atrium Franklin Ohio United States 45005
    573 Dayton Physicians LLC-Wayne Greenville Ohio United States 45331
    574 Wayne Hospital Greenville Ohio United States 45331
    575 Cleveland Clinic Cancer Center Independence Independence Ohio United States 44131
    576 Greater Dayton Cancer Center Kettering Ohio United States 45409
    577 First Dayton Cancer Care Kettering Ohio United States 45420
    578 Kettering Medical Center Kettering Ohio United States 45429
    579 Fairfield Medical Center Lancaster Ohio United States 43130
    580 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    581 Cleveland Clinic Cancer Center Mansfield Mansfield Ohio United States 44906
    582 Marietta Memorial Hospital Marietta Ohio United States 45750
    583 OhioHealth Marion General Hospital Marion Ohio United States 43302
    584 Toledo Clinic Cancer Centers-Maumee Maumee Ohio United States 43537
    585 Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio United States 43537
    586 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    587 UH Seidman Cancer Center at Landerbrook Health Center Mayfield Heights Ohio United States 44124
    588 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    589 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
    590 Dayton Physicians LLC-Signal Point Middletown Ohio United States 45042
    591 Knox Community Hospital Mount Vernon Ohio United States 43050
    592 Licking Memorial Hospital Newark Ohio United States 43055
    593 Newark Radiation Oncology Newark Ohio United States 43055
    594 Saint Charles Hospital Oregon Ohio United States 43616
    595 University Hospitals Parma Medical Center Parma Ohio United States 44129
    596 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
    597 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    598 North Coast Cancer Care Sandusky Ohio United States 44870
    599 UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio United States 44870
    600 Dayton Physicians LLC-Wilson Sidney Ohio United States 45365
    601 Springfield Regional Cancer Center Springfield Ohio United States 45504
    602 Springfield Regional Medical Center Springfield Ohio United States 45505
    603 Cleveland Clinic Cancer Center Strongsville Strongsville Ohio United States 44136
    604 ProMedica Flower Hospital Sylvania Ohio United States 43560
    605 The Toledo Hospital/Toledo Children's Hospital Toledo Ohio United States 43606
    606 Mercy Saint Anne Hospital Toledo Ohio United States 43623
    607 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    608 Dayton Physicians LLC-Upper Valley Troy Ohio United States 45373
    609 Upper Valley Medical Center Troy Ohio United States 45373
    610 University Hospitals Sharon Health Center Wadsworth Ohio United States 44281
    611 South Pointe Hospital Warrensville Heights Ohio United States 44122
    612 University Pointe West Chester Ohio United States 45069
    613 Saint Ann's Hospital Westerville Ohio United States 43081
    614 UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
    615 UHHS-Westlake Medical Center Westlake Ohio United States 44145
    616 Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio United States 44691
    617 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    618 Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma United States 73505
    619 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    620 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    621 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    622 Saint Charles Health System Bend Oregon United States 97701
    623 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    624 Providence Oncology and Hematology Care Southeast Clackamas Oregon United States 97015
    625 Bay Area Hospital Coos Bay Oregon United States 97420
    626 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    627 Providence Newberg Medical Center Newberg Oregon United States 97132
    628 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    629 Providence Willamette Falls Medical Center Oregon City Oregon United States 97045
    630 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    631 Providence Portland Medical Center Portland Oregon United States 97213
    632 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    633 Kaiser Permanente Northwest Portland Oregon United States 97227
    634 Salem Hospital Salem Oregon United States 97301
    635 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
    636 Abington Memorial Hospital Abington Pennsylvania United States 19001
    637 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    638 Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania United States 18015
    639 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    640 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
    641 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    642 Geisinger Medical Center Danville Pennsylvania United States 17822
    643 Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania United States 18201
    644 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    645 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    646 Lewistown Hospital Lewistown Pennsylvania United States 17044
    647 Riddle Memorial Hospital Media Pennsylvania United States 19063
    648 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
    649 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    650 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    651 Temple University Hospital Philadelphia Pennsylvania United States 19140
    652 Geisinger Cancer Services-Pottsville Pottsville Pennsylvania United States 17901
    653 Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania United States 18840
    654 Community Medical Center Scranton Pennsylvania United States 18510
    655 Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania United States 17870
    656 Grand View Hospital Sellersville Pennsylvania United States 18960
    657 Geisinger Medical Group State College Pennsylvania United States 16801
    658 Reading Hospital West Reading Pennsylvania United States 19611
    659 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    660 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    661 Roper Hospital Charleston South Carolina United States 29401
    662 Charleston Oncology - Roper Charleston South Carolina United States 29403
    663 Lowcountry Hematology Oncology PA-North Charleston Charleston South Carolina United States 29406
    664 Bon Secours Saint Francis Hospital Charleston South Carolina United States 29414
    665 Charleston Oncology - Saint Francis Charleston South Carolina United States 29414
    666 Lowcountry Hematology Oncology PA-West Ashley Charleston South Carolina United States 29414
    667 Medical University of South Carolina Charleston South Carolina United States 29425
    668 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    669 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29601
    670 Saint Francis Hospital Greenville South Carolina United States 29601
    671 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    672 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    673 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
    674 Saint Francis Cancer Center Greenville South Carolina United States 29607
    675 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    676 Self Regional Healthcare Greenwood South Carolina United States 29646
    677 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    678 Lowcountry Hematology Oncology PA-Mount Pleasant Mount Pleasant South Carolina United States 29464
    679 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    680 Prisma Health Cancer Institute - Spartanburg Spartanburg South Carolina United States 29307
    681 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    682 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    683 Wellmont Bristol Regional Medical Center Bristol Tennessee United States 37620
    684 Wellmont Medical Associates Oncology and Hematology-Bristol Bristol Tennessee United States 37620
    685 Memorial Hospital Chattanooga Tennessee United States 37404
    686 Integrity Oncology PLLC-Collierville Collierville Tennessee United States 38017
    687 Vanderbilt-Ingram Cancer Center Cool Springs Franklin Tennessee United States 37067
    688 Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee United States 37343
    689 Wellmont Medical Associates Oncology and Hematology-Johnson City Johnson City Tennessee United States 37604
    690 Regional Cancer Center at Indian Path Community Hospital Kingsport Tennessee United States 37660
    691 Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee United States 37660
    692 Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee United States 38120
    693 Baptist Memorial Hospital for Women Memphis Tennessee United States 38120
    694 Family Cancer Center-Memphis Memphis Tennessee United States 38120
    695 Vanderbilt Breast Center at One Hundred Oaks Nashville Tennessee United States 37204
    696 Meharry Medical College Nashville Tennessee United States 37208
    697 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    698 Memorial GYN Plus Ooltewah Tennessee United States 37363
    699 Texas Oncology-Austin Midtown Austin Texas United States 78705
    700 Texas Oncology - Central Austin Cancer Center Austin Texas United States 78731
    701 Texas Oncology - South Austin Cancer Center Austin Texas United States 78745
    702 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    703 Parkland Memorial Hospital Dallas Texas United States 75235
    704 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    705 UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas United States 76104
    706 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    707 Ben Taub General Hospital Houston Texas United States 77030
    708 Texas Oncology - Round Rock Cancer Center Round Rock Texas United States 78681
    709 Cancer Therapy and Research Center at The UT Health Science Center at San Antonio San Antonio Texas United States 78229
    710 University Hospital San Antonio Texas United States 78229
    711 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    712 Farmington Health Center Farmington Utah United States 84025
    713 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    714 South Jordan Health Center South Jordan Utah United States 84009
    715 Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont United States 05602
    716 University of Vermont Medical Center Burlington Vermont United States 05401
    717 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    718 Norris Cotton Cancer Center-North Saint Johnsbury Vermont United States 05819
    719 Wellmont Medical Associates-Bristol Bristol Virginia United States 24201
    720 Bon Secours Memorial Regional Medical Center Mechanicsville Virginia United States 23116
    721 Bon Secours Saint Francis Medical Center Midlothian Virginia United States 23114
    722 Southwest VA Regional Cancer Center Norton Virginia United States 24273
    723 Bon Secours Saint Mary's Hospital Richmond Virginia United States 23226
    724 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    725 Cancer Care Center at Island Hospital Anacortes Washington United States 98221
    726 Swedish Cancer Institute-Eastside Oncology Hematology Bellevue Washington United States 98005
    727 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    728 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    729 Harrison Medical Center Bremerton Washington United States 98310
    730 Highline Medical Center-Main Campus Burien Washington United States 98166
    731 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    732 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    733 Saint Elizabeth Hospital Enumclaw Washington United States 98022
    734 Providence Regional Cancer Partnership Everett Washington United States 98201
    735 Saint Francis Hospital Federal Way Washington United States 98003
    736 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    737 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    738 Saint Clare Hospital Lakewood Washington United States 98499
    739 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    740 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
    741 Minor and James Medical PLLC Seattle Washington United States 98104
    742 Pacific Gynecology Specialists Seattle Washington United States 98104
    743 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    744 Kaiser Permanente Washington Seattle Washington United States 98112
    745 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    746 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
    747 Rockwood Clinic Cancer Treatment Center-Valley Spokane Valley Washington United States 99216
    748 Rockwood Cancer Treatment Center-DHEC-Downtown Spokane Washington United States 99204
    749 Rockwood North Cancer Treatment Center Spokane Washington United States 99218
    750 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
    751 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
    752 Madigan Army Medical Center Tacoma Washington United States 98431
    753 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    754 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    755 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    756 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington United States 98902
    757 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
    758 West Virginia University Charleston Division Charleston West Virginia United States 25304
    759 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    760 Duluth Clinic Ashland Ashland Wisconsin United States 54806
    761 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    762 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    763 HSHS Sacred Heart Hospital Eau Claire Wisconsin United States 54701
    764 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
    765 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    766 Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin United States 54937
    767 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    768 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    769 Bellin Memorial Hospital Green Bay Wisconsin United States 54301
    770 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    771 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    772 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    773 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    774 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    775 Bay Area Medical Center Marinette Wisconsin United States 54143
    776 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    777 Marshfield Medical Center Marshfield Wisconsin United States 54449
    778 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    779 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    780 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    781 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    782 ProHealth D N Greenwald Center Mukwonago Wisconsin United States 53149
    783 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    784 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    785 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    786 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    787 Lakeview Medical Center-Marshfield Clinic Rice Lake Wisconsin United States 54868
    788 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    789 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    790 Ascension Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    791 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    792 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    793 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    794 Aurora Cancer Care-Waukesha Waukesha Wisconsin United States 53188
    795 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    796 UW Cancer Center at ProHealth Care Waukesha Wisconsin United States 53188
    797 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    798 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    799 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    800 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    801 Ascension Saint Clare's Hospital Weston Wisconsin United States 54476
    802 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    803 Aspirus UW Cancer Center Wisconsin Rapids Wisconsin United States 54494
    804 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    805 Big Horn Basin Cancer Center Cody Wyoming United States 82414
    806 Billings Clinic-Cody Cody Wyoming United States 82414
    807 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Davendra Sohal, Southwest Oncology Group

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT02562716
    Other Study ID Numbers:
    • S1505
    • NCI-2015-01236
    • S1505
    • S1505
    • U10CA180888
    First Posted:
    Sep 29, 2015
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Adenocarcinoma
    Pancreatic Neoplasms
    Gemcitabine
    Paclitaxel
    Camptothecin
    Albumin-Bound Paclitaxel
    Fluorouracil
    Oxaliplatin
    Irinotecan
    Pancrelipase
    Pancreatin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 147 participants were randomized, but 43 were found to be ineligible per central radiology review, and 1 was found to be ineligible due to incorrect primary tumor. One patient withdrew study consent prior to any therapy and was not evaluable. Therefore 102 were deemed eligible and analyzable for the primary analysis.
    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Period Title: Overall Study
    STARTED 55 47
    Participants Assessed for AEs 53 45
    COMPLETED 27 19
    NOT COMPLETED 28 28

    Baseline Characteristics

    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P Total
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
    Overall Participants 55 47 102
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    66
    64
    64
    Sex: Female, Male (Count of Participants)
    Female
    19
    34.5%
    23
    48.9%
    42
    41.2%
    Male
    36
    65.5%
    24
    51.1%
    60
    58.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    5.5%
    4
    8.5%
    7
    6.9%
    Not Hispanic or Latino
    51
    92.7%
    43
    91.5%
    94
    92.2%
    Unknown or Not Reported
    1
    1.8%
    0
    0%
    1
    1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    3.6%
    5
    10.6%
    7
    6.9%
    White
    52
    94.5%
    39
    83%
    91
    89.2%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    1.8%
    3
    6.4%
    4
    3.9%
    Zubrod Performance Status (Count of Participants)
    0
    34
    61.8%
    31
    66%
    65
    63.7%
    1
    21
    38.2%
    16
    34%
    37
    36.3%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival (OS)
    Description OS is the length of time between protocol registration and patient death
    Time Frame Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm.

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants.
    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Measure Participants 55 47
    Median (95% Confidence Interval) [Months]
    23.2
    23.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection mFOLFIRINOX ->Surg ->mFOLFIRINOX
    Comments For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .15
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Gem/Nab-P ->Surg ->Gem/Nab-P
    Comments For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .14
    Comments
    Method Log Rank
    Comments
    2. Secondary Outcome
    Title Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
    Description Only adverse events that are possibly, probably or definitely related to preoperative and postoperative chemotherapy are reported.
    Time Frame Duration of treatment and follow up until death or 4 years post registration.

    Outcome Measure Data

    Analysis Population Description
    Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment.
    Arm/Group Title mFOLFIRINOX->Surg->mFOLFIRINOX Gem/Nab-P->Surg->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Measure Participants 53 45
    Abdominal infection
    1
    1.8%
    0
    0%
    Acute kidney injury
    0
    0%
    1
    2.1%
    Alanine aminotransferase increased
    3
    5.5%
    2
    4.3%
    Allergic reaction
    1
    1.8%
    0
    0%
    Anemia
    4
    7.3%
    4
    8.5%
    Anorexia
    2
    3.6%
    0
    0%
    Aspartate aminotransferase increased
    2
    3.6%
    1
    2.1%
    Biliary tract infection
    0
    0%
    1
    2.1%
    Blood bilirubin increased
    1
    1.8%
    3
    6.4%
    Colonic perforation
    0
    0%
    1
    2.1%
    Constipation
    0
    0%
    1
    2.1%
    Dehydration
    1
    1.8%
    0
    0%
    Diarrhea
    8
    14.5%
    3
    6.4%
    Dysesthesia
    1
    1.8%
    0
    0%
    Dyspnea
    0
    0%
    1
    2.1%
    Fall
    1
    1.8%
    0
    0%
    Fatigue
    4
    7.3%
    3
    6.4%
    Febrile neutropenia
    0
    0%
    2
    4.3%
    Hepatobiliary disorders - Other, specify
    1
    1.8%
    0
    0%
    Hyperglycemia
    2
    3.6%
    2
    4.3%
    Hypertension
    0
    0%
    1
    2.1%
    Hypoalbuminemia
    0
    0%
    1
    2.1%
    Hypoglycemia
    0
    0%
    1
    2.1%
    Hypokalemia
    3
    5.5%
    1
    2.1%
    Hypomagnesemia
    0
    0%
    2
    4.3%
    Hyponatremia
    2
    3.6%
    2
    4.3%
    Infections and infestations - Other, specify
    1
    1.8%
    1
    2.1%
    Infusion related reaction
    1
    1.8%
    0
    0%
    Insomnia
    0
    0%
    1
    2.1%
    Leukocytosis
    1
    1.8%
    0
    0%
    Lung infection
    1
    1.8%
    2
    4.3%
    Lymphocyte count decreased
    0
    0%
    2
    4.3%
    Mucositis oral
    0
    0%
    1
    2.1%
    Myocardial infarction
    1
    1.8%
    0
    0%
    Nausea
    3
    5.5%
    1
    2.1%
    Neutrophil count decreased
    11
    20%
    17
    36.2%
    Non-cardiac chest pain
    0
    0%
    1
    2.1%
    Pancreatitis
    1
    1.8%
    0
    0%
    Papulopustular rash
    0
    0%
    1
    2.1%
    Peripheral motor neuropathy
    1
    1.8%
    0
    0%
    Peripheral sensory neuropathy
    5
    9.1%
    3
    6.4%
    Platelet count decreased
    3
    5.5%
    2
    4.3%
    Pneumonitis
    0
    0%
    1
    2.1%
    Rectal hemorrhage
    0
    0%
    1
    2.1%
    Respiratory failure
    0
    0%
    1
    2.1%
    Sepsis
    1
    1.8%
    2
    4.3%
    Skin infection
    1
    1.8%
    0
    0%
    Thromboembolic event
    2
    3.6%
    0
    0%
    Vomiting
    2
    3.6%
    0
    0%
    Weight loss
    2
    3.6%
    0
    0%
    White blood cell decreased
    1
    1.8%
    6
    12.8%
    3. Secondary Outcome
    Title Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.
    Description
    Time Frame Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants
    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Measure Participants 55 47
    Count of Participants [Participants]
    40
    72.7%
    33
    70.2%
    4. Secondary Outcome
    Title Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.
    Description R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins).
    Time Frame Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants undergoing surgical resection.
    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Measure Participants 40 33
    Count of Participants [Participants]
    34
    61.8%
    28
    59.6%
    5. Secondary Outcome
    Title Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.
    Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    Time Frame Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants.
    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Measure Participants 55 47
    Count of Participants [Participants]
    5
    9.1%
    10
    21.3%
    6. Secondary Outcome
    Title Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection.
    Description Pathologic response was evaluated after the patient had surgery, and was based on local pathology review of the resected surgical specimen, according to the following Tumor Regression Grade definitions: 0: Complete response - no residual tumor Moderate response - minimal residual cancer (single cells or small groups of cancer cells) Minimal response - residual cancer outgrown by fibrosis Poor or no response - no definite response identified (minimal or no tumor kill; extensive residual cancer)
    Time Frame Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants undergoing resection.
    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Measure Participants 40 33
    Complete Response
    1
    1.8%
    3
    6.4%
    Moderate Response
    9
    16.4%
    10
    21.3%
    Minimal Response
    12
    21.8%
    10
    21.3%
    Poor or No Response
    18
    32.7%
    10
    21.3%
    7. Secondary Outcome
    Title Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection.
    Description Loco-regional recurrence is defined as any evidence of new disease within the pancreatic tumor bed based on surveillance scans. The pancreatic tumor bed includes: Superior mesenteric artery and vein lymph nodes Lymph nodes in porta hepatis (bile duct, portal vein, hepatic artery lymph nodes) Lymph nodes around left renal vein, inferior vena cava or aorta Celiac axis lymph nodes. Distant Recurrence is defined as any evidence of new disease outside the primary tumor bed (liver, lungs, etc.) based on surveillance scans.
    Time Frame Up to 4 years

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants undergoing resection.
    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Measure Participants 40 33
    No Progression
    13
    23.6%
    17
    36.2%
    Loco-regional recurrence
    9
    16.4%
    4
    8.5%
    Distant recurrence
    13
    23.6%
    9
    19.1%
    Both loco-regional and distant recurrence
    5
    9.1%
    2
    4.3%
    Not assessed due to death (cardiac arrest) prior to start of post-op chemo
    0
    0%
    1
    2.1%
    8. Secondary Outcome
    Title Disease-free Survival From the Time of R0 or R1 Resection.
    Description Disease-free survival (DFS) is calculated for patients who undergo surgical resection (R0/R1). DFS will be measured from the date of surgical resection to date of first documentation of recurrence (loco-regional or distant) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact.
    Time Frame Up to 4 years

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants undergoing surgical resection.
    Arm/Group Title mFOLFIRINOX ->Surg ->mFOLFIRINOX Gem/Nab-P ->Surg ->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
    Measure Participants 40 33
    Median (95% Confidence Interval) [Months]
    10.9
    14.2

    Adverse Events

    Time Frame Duration of treatment and follow up until death or 4 years post registration.
    Adverse Event Reporting Description Adverse Events (AEs) are reported by CTCAE Version 5.0.
    Arm/Group Title mFOLFIRINOX->Surg->mFOLFIRINOX Gem/Nab-P->Surg->Gem/Nab-P
    Arm/Group Description Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment are included in the Serious Adverse Events and Other Adverse Events tables. All eligible participants were assessed for All-Cause Mortality. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity. Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment are included in the Serious Adverse Events and Other Adverse Events tables. All eligible participants were assessed for All-Cause Mortality.
    All Cause Mortality
    mFOLFIRINOX->Surg->mFOLFIRINOX Gem/Nab-P->Surg->Gem/Nab-P
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 32/55 (58.2%) 32/47 (68.1%)
    Serious Adverse Events
    mFOLFIRINOX->Surg->mFOLFIRINOX Gem/Nab-P->Surg->Gem/Nab-P
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/53 (5.7%) 5/45 (11.1%)
    Cardiac disorders
    Cardiac arrest 1/53 (1.9%) 0/45 (0%)
    Gastrointestinal disorders
    Colonic perforation 0/53 (0%) 1/45 (2.2%)
    Hepatobiliary disorders
    Hepatobiliary disorders-Other 1/53 (1.9%) 0/45 (0%)
    Infections and infestations
    Lung infection 0/53 (0%) 1/45 (2.2%)
    Sepsis 1/53 (1.9%) 1/45 (2.2%)
    Metabolism and nutrition disorders
    Hypomagnesemia 0/53 (0%) 1/45 (2.2%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 0/53 (0%) 1/45 (2.2%)
    Pneumonitis 0/53 (0%) 1/45 (2.2%)
    Respiratory failure 0/53 (0%) 1/45 (2.2%)
    Other (Not Including Serious) Adverse Events
    mFOLFIRINOX->Surg->mFOLFIRINOX Gem/Nab-P->Surg->Gem/Nab-P
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 53/53 (100%) 45/45 (100%)
    Blood and lymphatic system disorders
    Anemia 32/53 (60.4%) 37/45 (82.2%)
    Febrile neutropenia 0/53 (0%) 2/45 (4.4%)
    Leukocytosis 1/53 (1.9%) 1/45 (2.2%)
    Cardiac disorders
    Cardiac arrest 0/53 (0%) 1/45 (2.2%)
    Chest pain - cardiac 0/53 (0%) 1/45 (2.2%)
    Myocardial infarction 2/53 (3.8%) 0/45 (0%)
    Sinus bradycardia 1/53 (1.9%) 2/45 (4.4%)
    Sinus tachycardia 3/53 (5.7%) 6/45 (13.3%)
    Supraventricular tachycardia 0/53 (0%) 1/45 (2.2%)
    Ventricular fibrillation 0/53 (0%) 1/45 (2.2%)
    Ventricular tachycardia 0/53 (0%) 1/45 (2.2%)
    Ear and labyrinth disorders
    Hearing impaired 1/53 (1.9%) 1/45 (2.2%)
    Tinnitus 2/53 (3.8%) 1/45 (2.2%)
    Vertigo 2/53 (3.8%) 0/45 (0%)
    Eye disorders
    Blurred vision 4/53 (7.5%) 0/45 (0%)
    Dry eye 2/53 (3.8%) 1/45 (2.2%)
    Eye disorders-Other 3/53 (5.7%) 4/45 (8.9%)
    Eye pain 1/53 (1.9%) 3/45 (6.7%)
    Watering eyes 2/53 (3.8%) 0/45 (0%)
    Gastrointestinal disorders
    Abdominal distension 2/53 (3.8%) 3/45 (6.7%)
    Abdominal pain 24/53 (45.3%) 22/45 (48.9%)
    Anal pain 1/53 (1.9%) 0/45 (0%)
    Bloating 3/53 (5.7%) 6/45 (13.3%)
    Colitis 1/53 (1.9%) 0/45 (0%)
    Colonic perforation 1/53 (1.9%) 0/45 (0%)
    Constipation 15/53 (28.3%) 16/45 (35.6%)
    Dental caries 1/53 (1.9%) 0/45 (0%)
    Diarrhea 39/53 (73.6%) 29/45 (64.4%)
    Dry mouth 2/53 (3.8%) 3/45 (6.7%)
    Duodenal ulcer 0/53 (0%) 1/45 (2.2%)
    Dyspepsia 6/53 (11.3%) 7/45 (15.6%)
    Dysphagia 3/53 (5.7%) 1/45 (2.2%)
    Esophagitis 1/53 (1.9%) 0/45 (0%)
    Flatulence 4/53 (7.5%) 3/45 (6.7%)
    Gastric hemorrhage 0/53 (0%) 1/45 (2.2%)
    Gastritis 0/53 (0%) 2/45 (4.4%)
    Gastroesophageal reflux disease 2/53 (3.8%) 1/45 (2.2%)
    Gastrointestinal disorders-Other 4/53 (7.5%) 5/45 (11.1%)
    Gastrointestinal fistula 0/53 (0%) 2/45 (4.4%)
    Gastroparesis 2/53 (3.8%) 3/45 (6.7%)
    Hemorrhoids 3/53 (5.7%) 1/45 (2.2%)
    Ileus 0/53 (0%) 1/45 (2.2%)
    Malabsorption 1/53 (1.9%) 0/45 (0%)
    Mucositis oral 7/53 (13.2%) 6/45 (13.3%)
    Nausea 38/53 (71.7%) 29/45 (64.4%)
    Oral pain 1/53 (1.9%) 1/45 (2.2%)
    Pancreatic fistula 0/53 (0%) 1/45 (2.2%)
    Pancreatitis 1/53 (1.9%) 1/45 (2.2%)
    Rectal hemorrhage 0/53 (0%) 1/45 (2.2%)
    Toothache 1/53 (1.9%) 0/45 (0%)
    Upper gastrointestinal hemorrhage 1/53 (1.9%) 0/45 (0%)
    Vomiting 17/53 (32.1%) 16/45 (35.6%)
    General disorders
    Chills 8/53 (15.1%) 9/45 (20%)
    Edema limbs 3/53 (5.7%) 10/45 (22.2%)
    Fatigue 41/53 (77.4%) 38/45 (84.4%)
    Fever 10/53 (18.9%) 14/45 (31.1%)
    Flu like symptoms 2/53 (3.8%) 8/45 (17.8%)
    Gait disturbance 1/53 (1.9%) 0/45 (0%)
    General disorders and admin site conditions - Other 1/53 (1.9%) 2/45 (4.4%)
    Hypothermia 1/53 (1.9%) 0/45 (0%)
    Infusion related reaction 5/53 (9.4%) 1/45 (2.2%)
    Irritability 1/53 (1.9%) 0/45 (0%)
    Localized edema 1/53 (1.9%) 2/45 (4.4%)
    Malaise 3/53 (5.7%) 4/45 (8.9%)
    Neck edema 2/53 (3.8%) 0/45 (0%)
    Non-cardiac chest pain 3/53 (5.7%) 1/45 (2.2%)
    Pain 7/53 (13.2%) 13/45 (28.9%)
    Hepatobiliary disorders
    Bile duct stenosis 1/53 (1.9%) 1/45 (2.2%)
    Cholecystitis 0/53 (0%) 2/45 (4.4%)
    Immune system disorders
    Allergic reaction 4/53 (7.5%) 0/45 (0%)
    Infections and infestations
    Abdominal infection 1/53 (1.9%) 1/45 (2.2%)
    Biliary tract infection 0/53 (0%) 2/45 (4.4%)
    Bronchial infection 0/53 (0%) 1/45 (2.2%)
    Catheter related infection 0/53 (0%) 1/45 (2.2%)
    Enterocolitis infectious 0/53 (0%) 1/45 (2.2%)
    Gum infection 0/53 (0%) 1/45 (2.2%)
    Infections and infestations-Other 3/53 (5.7%) 2/45 (4.4%)
    Lung infection 1/53 (1.9%) 4/45 (8.9%)
    Mucosal infection 1/53 (1.9%) 0/45 (0%)
    Papulopustular rash 0/53 (0%) 1/45 (2.2%)
    Pleural infection 0/53 (0%) 1/45 (2.2%)
    Sepsis 0/53 (0%) 4/45 (8.9%)
    Sinusitis 0/53 (0%) 1/45 (2.2%)
    Skin infection 5/53 (9.4%) 4/45 (8.9%)
    Upper respiratory infection 3/53 (5.7%) 2/45 (4.4%)
    Urinary tract infection 2/53 (3.8%) 1/45 (2.2%)
    Wound infection 3/53 (5.7%) 4/45 (8.9%)
    Injury, poisoning and procedural complications
    Biliary anastomotic leak 0/53 (0%) 1/45 (2.2%)
    Bruising 1/53 (1.9%) 2/45 (4.4%)
    Fall 3/53 (5.7%) 1/45 (2.2%)
    Fracture 1/53 (1.9%) 0/45 (0%)
    Gastric anastomotic leak 0/53 (0%) 1/45 (2.2%)
    Injury, poison and procedural complications - Other 1/53 (1.9%) 0/45 (0%)
    Pancreatic anastomotic leak 1/53 (1.9%) 0/45 (0%)
    Postoperative hemorrhage 0/53 (0%) 1/45 (2.2%)
    Wound complication 1/53 (1.9%) 1/45 (2.2%)
    Investigations
    Activated partial thromboplastin time prolonged 1/53 (1.9%) 0/45 (0%)
    Alanine aminotransferase increased 23/53 (43.4%) 17/45 (37.8%)
    Alkaline phosphatase increased 25/53 (47.2%) 16/45 (35.6%)
    Aspartate aminotransferase increased 21/53 (39.6%) 17/45 (37.8%)
    Blood bilirubin increased 6/53 (11.3%) 8/45 (17.8%)
    Cholesterol high 1/53 (1.9%) 0/45 (0%)
    Creatinine increased 4/53 (7.5%) 7/45 (15.6%)
    INR increased 0/53 (0%) 2/45 (4.4%)
    Investigations-Other 4/53 (7.5%) 3/45 (6.7%)
    Lipase increased 0/53 (0%) 1/45 (2.2%)
    Lymphocyte count decreased 6/53 (11.3%) 7/45 (15.6%)
    Neutrophil count decreased 25/53 (47.2%) 31/45 (68.9%)
    Pancreatic enzymes decreased 1/53 (1.9%) 2/45 (4.4%)
    Platelet count decreased 20/53 (37.7%) 27/45 (60%)
    Weight gain 3/53 (5.7%) 1/45 (2.2%)
    Weight loss 21/53 (39.6%) 11/45 (24.4%)
    White blood cell decreased 15/53 (28.3%) 24/45 (53.3%)
    Metabolism and nutrition disorders
    Anorexia 24/53 (45.3%) 22/45 (48.9%)
    Dehydration 9/53 (17%) 7/45 (15.6%)
    Glucose intolerance 0/53 (0%) 1/45 (2.2%)
    Hypercalcemia 0/53 (0%) 1/45 (2.2%)
    Hyperglycemia 18/53 (34%) 14/45 (31.1%)
    Hyperkalemia 1/53 (1.9%) 3/45 (6.7%)
    Hypermagnesemia 1/53 (1.9%) 0/45 (0%)
    Hypernatremia 1/53 (1.9%) 1/45 (2.2%)
    Hypertriglyceridemia 1/53 (1.9%) 1/45 (2.2%)
    Hypoalbuminemia 25/53 (47.2%) 18/45 (40%)
    Hypocalcemia 11/53 (20.8%) 11/45 (24.4%)
    Hypoglycemia 1/53 (1.9%) 1/45 (2.2%)
    Hypokalemia 21/53 (39.6%) 19/45 (42.2%)
    Hypomagnesemia 10/53 (18.9%) 5/45 (11.1%)
    Hyponatremia 11/53 (20.8%) 13/45 (28.9%)
    Hypophosphatemia 1/53 (1.9%) 1/45 (2.2%)
    Metabolism and nutrition disorders - Other, specify 1/53 (1.9%) 3/45 (6.7%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 4/53 (7.5%) 6/45 (13.3%)
    Arthritis 0/53 (0%) 1/45 (2.2%)
    Back pain 6/53 (11.3%) 7/45 (15.6%)
    Bone pain 3/53 (5.7%) 4/45 (8.9%)
    Flank pain 1/53 (1.9%) 1/45 (2.2%)
    Generalized muscle weakness 7/53 (13.2%) 6/45 (13.3%)
    Muscle weakness lower limb 1/53 (1.9%) 1/45 (2.2%)
    Myalgia 2/53 (3.8%) 14/45 (31.1%)
    Neck pain 3/53 (5.7%) 0/45 (0%)
    Pain in extremity 2/53 (3.8%) 3/45 (6.7%)
    Nervous system disorders
    Ataxia 1/53 (1.9%) 0/45 (0%)
    Dizziness 10/53 (18.9%) 6/45 (13.3%)
    Dysarthria 1/53 (1.9%) 0/45 (0%)
    Dysesthesia 2/53 (3.8%) 1/45 (2.2%)
    Dysgeusia 11/53 (20.8%) 8/45 (17.8%)
    Dysphasia 1/53 (1.9%) 0/45 (0%)
    Headache 7/53 (13.2%) 8/45 (17.8%)
    Lethargy 0/53 (0%) 1/45 (2.2%)
    Memory impairment 1/53 (1.9%) 0/45 (0%)
    Movements involuntary 1/53 (1.9%) 0/45 (0%)
    Nervous system disorders-Other 5/53 (9.4%) 1/45 (2.2%)
    Paresthesia 6/53 (11.3%) 0/45 (0%)
    Peripheral motor neuropathy 4/53 (7.5%) 3/45 (6.7%)
    Peripheral sensory neuropathy 28/53 (52.8%) 19/45 (42.2%)
    Sinus pain 0/53 (0%) 1/45 (2.2%)
    Somnolence 0/53 (0%) 1/45 (2.2%)
    Spasticity 0/53 (0%) 1/45 (2.2%)
    Tremor 1/53 (1.9%) 0/45 (0%)
    Vasovagal reaction 0/53 (0%) 1/45 (2.2%)
    Psychiatric disorders
    Anxiety 7/53 (13.2%) 7/45 (15.6%)
    Confusion 2/53 (3.8%) 1/45 (2.2%)
    Delirium 0/53 (0%) 1/45 (2.2%)
    Depression 6/53 (11.3%) 11/45 (24.4%)
    Hallucinations 0/53 (0%) 1/45 (2.2%)
    Insomnia 5/53 (9.4%) 12/45 (26.7%)
    Restlessness 0/53 (0%) 1/45 (2.2%)
    Renal and urinary disorders
    Acute kidney injury 0/53 (0%) 1/45 (2.2%)
    Hematuria 0/53 (0%) 1/45 (2.2%)
    Renal and urinary disorders-Other 1/53 (1.9%) 0/45 (0%)
    Renal calculi 1/53 (1.9%) 0/45 (0%)
    Renal colic 1/53 (1.9%) 0/45 (0%)
    Urinary frequency 0/53 (0%) 2/45 (4.4%)
    Urinary incontinence 1/53 (1.9%) 0/45 (0%)
    Urinary retention 1/53 (1.9%) 0/45 (0%)
    Urine discoloration 0/53 (0%) 1/45 (2.2%)
    Reproductive system and breast disorders
    Genital edema 0/53 (0%) 2/45 (4.4%)
    Scrotal pain 0/53 (0%) 1/45 (2.2%)
    Respiratory, thoracic and mediastinal disorders
    Atelectasis 0/53 (0%) 1/45 (2.2%)
    Cough 5/53 (9.4%) 8/45 (17.8%)
    Dyspnea 5/53 (9.4%) 10/45 (22.2%)
    Epistaxis 0/53 (0%) 5/45 (11.1%)
    Hiccups 0/53 (0%) 1/45 (2.2%)
    Hoarseness 2/53 (3.8%) 1/45 (2.2%)
    Hypoxia 0/53 (0%) 1/45 (2.2%)
    Nasal congestion 1/53 (1.9%) 2/45 (4.4%)
    Pleural effusion 0/53 (0%) 1/45 (2.2%)
    Pleuritic pain 1/53 (1.9%) 0/45 (0%)
    Pneumonitis 0/53 (0%) 1/45 (2.2%)
    Postnasal drip 3/53 (5.7%) 1/45 (2.2%)
    Productive cough 0/53 (0%) 3/45 (6.7%)
    Resp, thoracic and mediastinal disorders - Other 0/53 (0%) 1/45 (2.2%)
    Respiratory failure 0/53 (0%) 2/45 (4.4%)
    Sinus disorder 0/53 (0%) 1/45 (2.2%)
    Sore throat 1/53 (1.9%) 4/45 (8.9%)
    Wheezing 1/53 (1.9%) 0/45 (0%)
    Skin and subcutaneous tissue disorders
    Alopecia 5/53 (9.4%) 19/45 (42.2%)
    Dry skin 2/53 (3.8%) 1/45 (2.2%)
    Hyperhidrosis 1/53 (1.9%) 1/45 (2.2%)
    Nail discoloration 0/53 (0%) 1/45 (2.2%)
    Pain of skin 2/53 (3.8%) 2/45 (4.4%)
    Pruritus 1/53 (1.9%) 5/45 (11.1%)
    Purpura 1/53 (1.9%) 0/45 (0%)
    Rash acneiform 0/53 (0%) 2/45 (4.4%)
    Rash maculo-papular 5/53 (9.4%) 7/45 (15.6%)
    Skin and subcutaneous tissue disorders - Other 3/53 (5.7%) 3/45 (6.7%)
    Skin ulceration 2/53 (3.8%) 0/45 (0%)
    Vascular disorders
    Flushing 1/53 (1.9%) 1/45 (2.2%)
    Hot flashes 1/53 (1.9%) 3/45 (6.7%)
    Hypertension 8/53 (15.1%) 11/45 (24.4%)
    Hypotension 8/53 (15.1%) 8/45 (17.8%)
    Superficial thrombophlebitis 0/53 (0%) 1/45 (2.2%)
    Thromboembolic event 6/53 (11.3%) 3/45 (6.7%)
    Vascular disorders-Other 0/53 (0%) 2/45 (4.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title SWOG Statistician
    Organization SWOG Statistics and Data Management Center
    Phone 2066674623
    Email smcdonou@fredhutch.org
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT02562716
    Other Study ID Numbers:
    • S1505
    • NCI-2015-01236
    • S1505
    • S1505
    • U10CA180888
    First Posted:
    Sep 29, 2015
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021