S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01498289
Collaborator
National Cancer Institute (NCI) (NIH)
213
508
2
91.6
0.4
0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells.

PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:
  • To assess progression-free survival of high-excision repair cross-complementing 1(ERCC1) patients with advanced or metastatic cancer of the esophagus, stomach, or gastroesophageal junction (GEJ) treated with FOLFOX comprising oxaliplatin, leucovorin calcium, and fluorouracil compared to those treated with irinotecan hydrochloride plus docetaxel.

  • To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to those treated with irinotecan hydrochloride plus docetaxel.

  • To assess progression-free survival of low-ERCC1 patients with advanced or metastatic cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to high-ERCC1 patients treated with FOLFOX.

  • To assess overall survival of and toxicities in each of the two treatment arms in this group of patients.

  • To assess the response probability (confirmed and unconfirmed, complete and partial responses) in the subset of patients with measurable disease in each of the two treatment arms.

  • To explore whether there is evidence of interaction between treatment arm and ERCC1 expression in this group of patients. (Exploratory)

  • To bank tissue and blood for future translational medicine studies; a) To explore the relationship of ERCC-1 and ERCC-2 single nucleotide polymorphism (SNP) genotypes with clinical outcome in these patients; and b) To explore the association between germline variations in these SNPs and ERCC-1 mRNA expression in these patients. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to ERCC1 expression (high [≥ 1.7] vs low [< 1.7]), and disease site (esophageal vs gastric/gastroesophageal junction). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (FOLFOX): Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples may be collected for ERCC1 expression analysis and future research studies.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
213 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1(Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer
Actual Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Sep 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

FOLFOX regimen: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Drug: FOLFOX regimen
Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

Drug: fluorouracil
400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.
Other Names:
  • 5-fluorouracil
  • 5-FU
  • NSC-19893
  • Drug: leucovorin calcium
    400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
    Other Names:
  • NSC-3590
  • Drug: oxaliplatin
    85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
    Other Names:
  • Eloxatin
  • NSC-266046
  • Experimental: Arm II

    Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

    Drug: docetaxel
    30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
    Other Names:
  • Taxotere
  • RP56976
  • NSC-628503
  • Drug: irinotecan hydrochloride
    65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
    Other Names:
  • CPT-11
  • NSC-616348
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) in High-ERCC1 Patients [Up to 3 years after registration]

      Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

    2. PFS in Low-ERCC1 Participants [Up to 3 years after registration]

      Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

    3. Overall Survival (OS) [Up to 3 years after registration]

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

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) [Up to 3 years after registration]

      ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. 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.

    2. PFS Variation by ERCC1 [up to 3 years after registration]

      Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first. Participants were divided into subgroups according to ERCC1 quartiles to assess whether the differences in PFS between the two treatment arms varied by ERCC1 levels.

    3. Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs [Duration of treatment and follow up until death or 3 years post registration]

      Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)

    • Patients must not have received treatment for metastatic or unresectable disease

    • Patients must not have brain metastases

    • Patients must have measurable and/or non-measurable disease

    • Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, a second specimen must be submitted for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized

    • Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration

    PATIENT CHARACTERISTICS:
    • Zubrod performance status of 0-1

    • Hemoglobin ≥ 9 g/dL

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

    • Platelets ≥ 100,000/mcL

    • Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor

    • AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN

    • Serum creatinine < 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance > 60 mL/min

    • Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0

    • Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method

    • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years

    PRIOR CONCURRENT THERAPY:
    • See Disease Characteristics

    • All palliative radiation therapy alone must be completed at least 14 days prior to registration

    • Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer while on this protocol treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36688
    2 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    3 Sutter Auburn Faith Hospital Auburn California United States 95602
    4 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    5 Mills - Peninsula Hospitals Burlingame California United States 94010
    6 Sutter Davis Hospital Davis California United States 95616
    7 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    8 University of Southern California/Norris Cancer Center Los Angeles California United States 90033
    9 Fremont - Rideout Cancer Center Marysville California United States 95901
    10 Memorial Medical Center Modesto California United States 95355
    11 Palo Alto Medical Foundation-Camino Division Mountain View California United States 94040
    12 Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California United States 94040
    13 Sutter Cancer Research Consortium Novato California United States 94945
    14 University of California Medical Center At Irvine-Orange Campus Orange California United States 92868
    15 Palo Alto Medical Foundation Health Care Palo Alto California United States 94301
    16 Valley Medical Oncology Consultants Pleasanton California United States 94588
    17 Sutter Roseville Medical Center Roseville California United States 95661
    18 Sutter General Hospital Sacramento California United States 95816
    19 University of California at Davis Cancer Center Sacramento California United States 95817
    20 California Pacific Medical Center-Pacific Campus San Francisco California United States 94118
    21 Palo Alto Medical Foundation-Santa Cruz Santa Cruz California United States 95065
    22 Sutter Pacific Medical Foundation Santa Rosa California United States 95403
    23 Palo Atlo Medical Foundation-Sunnyvale Sunnyvale California United States 94806
    24 Tahoe Forest Cancer Center Truckee California United States 96161
    25 Sutter Solano Medical Center/Cancer Center Vallejo California United States 94589
    26 The Medical Center of Aurora Aurora Colorado United States 80012
    27 Boulder Community Hospital Boulder Colorado United States 80301
    28 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    29 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    30 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    31 Porter Adventist Hospital Denver Colorado United States 80210
    32 Exempla Saint Joseph Hospital Denver Colorado United States 80218
    33 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    34 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
    35 Rocky Mountain Cancer Centers-Rose Denver Colorado United States 80220
    36 Rose Medical Center Denver Colorado United States 80220
    37 Colorado Cancer Research Program CCOP Denver Colorado United States 80224-2522
    38 Colorado Blood Cancer Institute Denver Colorado United States 80907
    39 Mercy Medical Center Durango Colorado United States 81301
    40 Comprehensive Cancer Care and Research Institute of Colorado LLC Englewood Colorado United States 80113
    41 Swedish Medical Center Englewood Colorado United States 80113
    42 Poudre Valley Hospital Fort Collins Colorado United States 80524
    43 Mountain Blue Cancer Care Center Golden Colorado United States 80401
    44 North Colorado Medical Center Greeley Colorado United States 80631
    45 Breast Cancer Care Consultants Greenwood Village Colorado United States 80111
    46 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
    47 Saint Anthony Hospital Lakewood Colorado United States 80228
    48 Littleton Adventist Hospital Littleton Colorado United States 80122
    49 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
    50 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    51 Longmont United Hospital Longmont Colorado United States 80501
    52 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    53 McKee Medical Center Loveland Colorado United States 80539
    54 Parker Adventist Hospital Parker Colorado United States 80138
    55 Rocky Mountain Cancer Centers-Parker Parker Colorado United States 80138
    56 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    57 Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado United States 81008
    58 Exempla Lutheran Medical Center Wheat Ridge Colorado United States 80033
    59 Saint Francis Hospital and Medical Center Hartford Connecticut United States 06105
    60 Beebe Medical Center Lewes Delaware United States 19958
    61 Christiana Gynecologic Oncology LLC Newark Delaware United States 19713
    62 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    63 Helen F Graham Cancer Center Newark Delaware United States 19713
    64 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    65 Regional Hematology and Oncology PA Newark Delaware United States 19713
    66 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    67 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    68 Nanticoke Memorial Hospital Seaford Delaware United States 19973
    69 Christiana Care Health System-Wilmington Hospital Wilmington Delaware United States 19801
    70 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    71 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    72 Memorial Healthcare System - Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    73 Jupiter Medical Center Jupiter Florida United States 33458
    74 Mount Sinai Medical Center Miami Beach Florida United States 33140
    75 Florida Hospital Orlando Florida United States 32803
    76 Memorial Hospital West Pembroke Pines Florida United States 33028
    77 Phoebe Putney Memorial Hospital Albany Georgia United States 31701
    78 John B Amos Cancer Center Columbus Georgia United States 31904
    79 Memorial University Medical Center Savannah Georgia United States 31404
    80 Oncare Hawaii Inc-Pali Momi 'Aiea Hawaii United States 96701
    81 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    82 Oncare Hawaii Inc-POB II Honolulu Hawaii United States 96813
    83 Queen's Medical Center Honolulu Hawaii United States 96813
    84 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    85 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    86 OnCare Hawaii-Liliha Honolulu Hawaii United States 96817-3169
    87 Kuakini Medical Center Honolulu Hawaii United States 96817
    88 Oncare Hawaii Inc-Kuakini Honolulu Hawaii United States 96817
    89 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    90 Castle Medical Center Kailua Hawaii United States 96734
    91 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    92 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    93 Saint Joseph Regional Medical Center Lewiston Idaho United States 83501
    94 Idaho Urologic Institute-Meredian Meridian Idaho United States 83642
    95 Kootenai Cancer Center Post Falls Idaho United States 83854
    96 Saint Anthony's Health Alton Illinois United States 62002
    97 Illinois CancerCare-Bloomington Bloomington Illinois United States 61701
    98 Saint Joseph Medical Center Bloomington Illinois United States 61701
    99 Graham Hospital Association Canton Illinois United States 61520
    100 Illinois CancerCare-Canton Canton Illinois United States 61520
    101 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    102 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    103 Memorial Hospital Carthage Illinois United States 62321
    104 Centralia Oncology Clinic Centralia Illinois United States 62801
    105 Hematology and Oncology Associates Chicago Illinois United States 60611
    106 Northwestern University Chicago Illinois United States 60611
    107 University of Illinois Chicago Illinois United States 60612
    108 Cancer Care Center of Decatur Decatur Illinois United States 62526
    109 Central Illinois CCOP Decatur Illinois United States 62526
    110 Decatur Memorial Hospital Decatur Illinois United States 62526
    111 Crossroads Cancer Center Effingham Illinois United States 62401
    112 Eureka Hospital Eureka Illinois United States 61530
    113 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    114 Illinois CancerCare Galesburg Galesburg Illinois United States 61401
    115 Illinois CancerCare-Galesburg Cottage Plaza Office Galesburg Illinois United States 61401
    116 Illinois CancerCare-Havana Havana Illinois United States 62644
    117 Mason District Hospital Havana Illinois United States 62644
    118 Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois United States 60035
    119 Presence Saint Mary's Hospital Kankakee Illinois United States 60901
    120 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    121 Adventist La Grange Memorial Hospital La Grange Illinois United States 60525
    122 North Shore Hematology Oncology Libertyville Illinois United States 60048
    123 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    124 Mcdonough District Hospital Macomb Illinois United States 61455
    125 Loyola University Medical Center Maywood Illinois United States 60153
    126 Garneau, Stewart C MD (UIA Investigator) Moline Illinois United States 61265
    127 Porubcin, Michael MD (UIA Investigator) Moline Illinois United States 61265
    128 Spector, David MD (UIA Investigator) Moline Illinois United States 61265
    129 Trinity Medical Center Moline Illinois United States 61265
    130 Holy Family Medical Center Monmouth Illinois United States 61462
    131 Illinois CancerCare-Monmouth Monmouth Illinois United States 61462
    132 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    133 Hematology Oncology Consultants Limited Naperville Illinois United States 60540
    134 Illinois Cancer Specialists-Niles Niles Illinois United States 60714
    135 Bromenn Regional Medical Center Normal Illinois United States 61761
    136 Community Cancer Center Foundation Normal Illinois United States 61761
    137 Illinois CancerCare-Community Cancer Center Normal Illinois United States 61761
    138 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    139 Ottawa Regional Hospital and Healthcare Center Ottawa Illinois United States 61350
    140 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    141 Pekin Cancer Treatment Center Pekin Illinois United States 61554
    142 Methodist Medical Center of Illinois Peoria Illinois United States 61603
    143 Proctor Hospital Peoria Illinois United States 61614
    144 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    145 Illinois Oncology Research Association CCOP Peoria Illinois United States 61615
    146 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    147 Illinois CancerCare-Peru Peru Illinois United States 61354
    148 Illinois Valley Hospital Peru Illinois United States 61354
    149 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    150 Perry Memorial Hospital Princeton Illinois United States 61356
    151 SwedishAmerican Regional Cancer Center/ACT Rockford Illinois United States 61107
    152 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois United States 60076
    153 Illinois CancerCare-Spring Valley Spring Valley Illinois United States 61362
    154 Memorial Medical Center Springfield Illinois United States 62781-0001
    155 Elkhart Clinic Elkhart Indiana United States 46514-2098
    156 Michiana Hematology Oncology PC-Elkhart Elkhart Indiana United States 46514
    157 Elkhart General Hospital Elkhart Indiana United States 46515
    158 Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana United States 46845
    159 Franciscan Saint Francis Health-Indianapolis Indianapolis Indiana United States 46237
    160 Community Howard Regional Health Kokomo Indiana United States 46904
    161 IU Health La Porte Hospital La Porte Indiana United States 46350
    162 Premier Oncology Hematology Associates Merrillville Indiana United States 46410
    163 Memorial Regional Cancer Center Day Road Mishawaka Indiana United States 46544
    164 Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana United States 46545-1470
    165 Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana United States 46545-1470
    166 Cancer Care Partners LLC Mishawaka Indiana United States 46545
    167 Michiana Hematology Oncology PC-Plymouth Plymouth Indiana United States 46563
    168 Reid Hospital and Health Care Services Richmond Indiana United States 47374
    169 Memorial Hospital of South Bend South Bend Indiana United States 46601
    170 Michiana Hematology Oncology PC-South Bend South Bend Indiana United States 46601
    171 South Bend Clinic South Bend Indiana United States 46617
    172 Northern Indiana Cancer Research Consortium South Bend Indiana United States 46628
    173 Michiana Hematology Oncology-PC Westville Westville Indiana United States 46391
    174 Mary Greeley Medical Center Ames Iowa United States 50010
    175 McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa United States 50010
    176 Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa United States 52722
    177 Hematology Oncology Associates-Quad Cities Bettendorf Iowa United States 52722
    178 McFarland Clinic PC-Boone Boone Iowa United States 50036
    179 Genesis Medical Center - East Campus Davenport Iowa United States 52803
    180 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
    181 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
    182 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
    183 Siouxland Hematology Oncology Associates Sioux City Iowa United States 51101
    184 Mercy Medical Center-Sioux City Sioux City Iowa United States 51104
    185 Saint Luke's Regional Medical Center Sioux City Iowa United States 51104
    186 Covenant Medical Center Waterloo Iowa United States 50702
    187 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    188 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    189 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    190 Newman Regional Health Emporia Kansas United States 66801
    191 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    192 Saint Catherine Hospital Garden City Kansas United States 67846
    193 Saint Rose Ambulatory and Surgery Center Great Bend Kansas United States 67530
    194 Hays Medical Center Hays Kansas United States 67601
    195 Promise Regional Medical Center-Hutchinson Hutchinson Kansas United States 65702
    196 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    197 Kansas City Cancer Center-West Kansas City Kansas United States 66112
    198 Providence Medical Center Kansas City Kansas United States 66112
    199 University of Kansas Medical Center Kansas City Kansas United States 66160
    200 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    201 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    202 Cancer Center of Kansas-Liberal Liberal Kansas United States 67901
    203 Cancer Center of Kansas-Manhattan Manhattan Kansas United States 66502
    204 Cancer Center of Kansas - McPherson McPherson Kansas United States 67460
    205 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    206 Menorah Medical Center Overland Park Kansas United States 66209
    207 Kansas City Cancer Centers-Southwest Overland Park Kansas United States 66210
    208 Saint Luke's South Hospital Overland Park Kansas United States 66213
    209 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    210 Via Christi Hospital-Pittsburg Pittsburg Kansas United States 66762
    211 Kansas City CCOP Prairie Village Kansas United States 66208
    212 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    213 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    214 Salina Regional Health Center Salina Kansas United States 67401
    215 Kansas City Cancer Center-Shawnee Mission Shawnee Mission Kansas United States 66204
    216 Saint Francis Hospital and Medical Center - Topeka Topeka Kansas United States 66606
    217 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    218 Associates In Womens Health Wichita Kansas United States 67208
    219 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    220 Cancer Center of Kansas - Main Office Wichita Kansas United States 67214
    221 Via Christi Regional Medical Center Wichita Kansas United States 67214
    222 Wichita CCOP Wichita Kansas United States 67214
    223 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    224 Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky United States 41017
    225 Ochsner Health Center-Summa Baton Rouge Louisiana United States 70809
    226 Ochsner Baptist Medical Center New Orleans Louisiana United States 70115
    227 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    228 Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana United States 71130
    229 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
    230 Eastern Maine Medical Center Bangor Maine United States 04401
    231 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    232 Union Hospital of Cecil County Elkton Maryland United States 21921
    233 Frederick Memorial Hospital Frederick Maryland United States 21701
    234 Bixby Medical Center Adrian Michigan United States 49221
    235 Hickman Cancer Center Adrian Michigan United States 49221
    236 Veteran's Administration Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    237 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106-0995
    238 Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor Michigan United States 48106
    239 University of Michigan University Hospital Ann Arbor Michigan United States 48109
    240 University of Michigan Ann Arbor Michigan United States 48109
    241 Bronson Battle Creek Battle Creek Michigan United States 49017
    242 Spectrum Health Big Rapids Hospital Big Rapids Michigan United States 49307
    243 Oakwood Hospital and Medical Center Dearborn Michigan United States 48124
    244 Henry Ford Hospital Detroit Michigan United States 48202
    245 Saint John Hospital and Medical Center Detroit Michigan United States 48236
    246 Green Bay Oncology - Escanaba Escanaba Michigan United States 49431
    247 Hurley Medical Center Flint Michigan United States 48502
    248 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    249 Genesys Regional Medical Center Grand Blanc Michigan United States 48439
    250 Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
    251 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    252 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    253 Green Bay Oncology - Iron Mountain Iron Mountain Michigan United States 49801
    254 Allegiance Health Jackson Michigan United States 49201
    255 Borgess Medical Center Kalamazoo Michigan United States 49001
    256 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    257 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    258 Sparrow Hospital Lansing Michigan United States 48912
    259 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    260 Community Cancer Center of Monroe Monroe Michigan United States 48162
    261 Mercy Memorial Hospital Monroe Michigan United States 48162
    262 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    263 Lakeland Community Hospital Niles Michigan United States 49120
    264 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341-2985
    265 Saint Joseph Mercy Port Huron Port Huron Michigan United States 48060
    266 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    267 Saint Mary's of Michigan Saginaw Michigan United States 48601
    268 Lakeland Hospital Saint Joseph Michigan United States 49085
    269 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    270 Munson Medical Center Traverse City Michigan United States 49684
    271 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    272 Sanford Clinic North-Bemidgi Bemidji Minnesota United States 56601
    273 University of Mississippi Medical Center Jackson Mississippi United States 39216
    274 Singing River Hospital Pascagoula Mississippi United States 39581
    275 Central Care Cancer Center-Carrie J Babb Cancer Center Bolivar Missouri United States 65613
    276 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    277 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    278 Centerpoint Medical Center LLC Independence Missouri United States 64057
    279 Capital Region Medical Center-Goldschmidt Cancer Center Jefferson City Missouri United States 65109
    280 Freeman Health System Joplin Missouri United States 64804
    281 Truman Medical Center Kansas City Missouri United States 64108
    282 Saint Luke's Cancer Institute Kansas City Missouri United States 64111
    283 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    284 North Kansas City Hospital Kansas City Missouri United States 64116
    285 Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri United States 64118
    286 Kansas City Cancer Center - South Kansas City Missouri United States 64131
    287 Research Medical Center Kansas City Missouri United States 64132
    288 Kansas City Cancer Centers - North Kansas City Missouri United States 64154
    289 Kansas City Cancer Center-Lee's Summit Lee's Summit Missouri United States 64064
    290 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    291 Liberty Hospital Liberty Missouri United States 64068
    292 Phelps County Regional Medical Center Rolla Missouri United States 65401
    293 Saint John's Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    294 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    295 Saint Joseph Oncology Inc Saint Joseph Missouri United States 64507
    296 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    297 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    298 Comprehensive Cancer Care PC Saint Louis Missouri United States 63141
    299 Saint John's Mercy Medical Center Saint Louis Missouri United States 63141
    300 Mercy Hospital Springfield Springfield Missouri United States 65804
    301 Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield Missouri United States 65804
    302 CoxHealth South Hospital Springfield Missouri United States 65807
    303 Montana Cancer Consortium CCOP Billings Montana United States 59101
    304 Saint Vincent Healthcare Billings Montana United States 59101
    305 Billings Clinic Billings Montana United States 59107-7000
    306 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    307 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    308 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    309 Big Sky Oncology Great Falls Montana United States 59405
    310 Saint Peter's Community Hospital Helena Montana United States 59601
    311 Kalispell Regional Medical Center Kalispell Montana United States 59901
    312 Montana Cancer Specialists Missoula Montana United States 59802
    313 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    314 Good Samaritan Hospital Kearney Nebraska United States 68847
    315 New Hampshire Oncology-Hematology PA Concord New Hampshire United States 03301
    316 New Hampshire Oncology Hematology Associates Hooksett New Hampshire United States 03106
    317 LRGHealthcare-Lakes Region General Hospital Laconia New Hampshire United States 03246
    318 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    319 Monmouth Medical Center Long Branch New Jersey United States 07740
    320 UMDNJ - New Jersey Medical School Newark New Jersey United States 07103
    321 Inspira Medical Center Vineland Vineland New Jersey United States 08360
    322 University of New Mexico Albuquerque New Mexico United States 87106
    323 Arnot Ogden Medical Center Elmira New York United States 14905
    324 Glens Falls Hospital Glens Falls New York United States 12801
    325 New York University Langone Medical Center New York New York United States 10016
    326 University of Rochester Rochester New York United States 14642
    327 Randolph Hospital Asheboro North Carolina United States 27203
    328 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    329 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    330 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    331 Cone Health Cancer Center Greensboro North Carolina United States 27403
    332 Hendersonville Hematology and Oncology at Pardee Hendersonville North Carolina United States 28739
    333 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    334 Park Ridge Hospital Breast Health Center Hendersonville North Carolina United States 28792
    335 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    336 Kinston Medical Specialists PA Kinston North Carolina United States 28501
    337 FirstHealth of the Carolinas-Moore Regional Hosiptal Pinehurst North Carolina United States 28374
    338 Annie Penn Memorial Hospital Reidsville North Carolina United States 27320
    339 Rutherford Hospital Rutherfordton North Carolina United States 28139
    340 Iredell Memorial Hospital Statesville North Carolina United States 28677
    341 Southeastern Medical Oncology Center-Wilson Wilson North Carolina United States 27893
    342 Southeast Cancer Control Consortium CCOP Winston-Salem North Carolina United States 27104
    343 Roger Maris Cancer Center Fargo North Dakota United States 58122
    344 Sanford Clinic North-Fargo Fargo North Dakota United States 58122
    345 Sanford Medical Center-Fargo Fargo North Dakota United States 58122
    346 Altru Cancer Center Grand Forks North Dakota United States 58201
    347 Summa Akron City Hospital/Cooper Cancer Center Akron Ohio United States 44304
    348 Akron General Medical Center Akron Ohio United States 44307
    349 Summa Barberton Hospital Barberton Ohio United States 44203
    350 Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio United States 43402
    351 Oncology Hematology Care Inc-Mercy West Cincinnati Ohio United States 45211
    352 Oncology and Hematology Care Inc-Taft Cincinnati Ohio United States 45219
    353 Oncology Hematology Care Inc - Anderson Cincinnati Ohio United States 45230
    354 Oncology Hematology Care Inc - Kenwood Cincinnati Ohio United States 45236
    355 Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio United States 45242
    356 University of Cincinnati Cincinnati Ohio United States 45267
    357 MetroHealth Medical Center Cleveland Ohio United States 44109
    358 Ohio State University Medical Center Columbus Ohio United States 43210
    359 Grandview Hospital Dayton Ohio United States 45405
    360 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    361 Miami Valley Hospital Dayton Ohio United States 45409
    362 Samaritan North Health Center Dayton Ohio United States 45415
    363 Dayton CCOP Dayton Ohio United States 45420
    364 Hematology Oncology Center Incorporated Elyria Ohio United States 44035
    365 Mercy Cancer Center-Elyria Elyria Ohio United States 44035
    366 Oncology Hematology Care Inc-Healthplex Fairfield Ohio United States 45014
    367 Blanchard Valley Hospital Findlay Ohio United States 45840
    368 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    369 Wayne Hospital Greenville Ohio United States 45331
    370 Kettering Medical Center Kettering Ohio United States 45429
    371 Saint Rita's Medical Center Lima Ohio United States 45801
    372 Lima Memorial Hospital Lima Ohio United States 45804
    373 Toledo Clinic Cancer Centers-Maumee Maumee Ohio United States 43537
    374 Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio United States 43537
    375 Saint Charles Hospital Oregon Ohio United States 43616
    376 Toledo Clinic Cancer Centers-Oregon Oregon Ohio United States 43616
    377 Flower Hospital Sylvania Ohio United States 43560
    378 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
    379 The Toledo Hospital/Toledo Children's Hospital Toledo Ohio United States 43606
    380 Saint Vincent Mercy Medical Center Toledo Ohio United States 43608
    381 University of Toledo Toledo Ohio United States 43614
    382 Toledo Community Hospital Oncology Program CCOP Toledo Ohio United States 43617
    383 Mercy Saint Anne Hospital Toledo Ohio United States 43623
    384 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    385 Upper Valley Medical Center Troy Ohio United States 45373
    386 Fulton County Health Center Wauseon Ohio United States 43567
    387 Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio United States 45433-5529
    388 Greene Memorial Hospital Xenia Ohio United States 45385
    389 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    390 Oklahoma Oncology Inc Tulsa Oklahoma United States 74104
    391 Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma United States 74136
    392 Warren Cancer Research Foundation Tulsa Oklahoma United States 74136
    393 Tulsa Cancer Institute Tulsa Oklahoma United States 74146
    394 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    395 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
    396 Providence Newberg Medical Center Newberg Oregon United States 97132
    397 Providence Willamette Falls Medical Center Oregon City Oregon United States 97045
    398 Providence Portland Medical Center Portland Oregon United States 97213
    399 Western Oncology Research Consortium Portland Oregon United States 97213
    400 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    401 Lehigh Valley Hospital Allentown Pennsylvania United States 18105
    402 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    403 Lancaster General Hospital Lancaster Pennsylvania United States 17604
    404 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    405 Temple University Hospital Philadelphia Pennsylvania United States 19140
    406 University of Pittsburgh Pittsburgh Pennsylvania United States 15232
    407 AnMed Health Cancer Center Anderson South Carolina United States 29621
    408 AnMed Health Hospital Anderson South Carolina United States 29621
    409 Roper Hospital Charleston South Carolina United States 29401
    410 Charleston Hematology Oncology Associates-Roper Charleston South Carolina United States 29403
    411 Lowcountry Hematology Oncology PA-Charleston Charleston South Carolina United States 29406
    412 Charleston Hematology Oncology Associates PA-St. Francis Charleston South Carolina United States 29414
    413 Lowcountry Hematology Oncology PA-West Ashley Charleston South Carolina United States 29414
    414 Greenville Health System Cancer Institute-Easley Easley South Carolina United States 29640
    415 Saint Francis Hospital Greenville South Carolina United States 29601
    416 Greenville Health System Cancer Institute-Andrews Greenville South Carolina United States 29605
    417 Greenville Health System Cancer Institute-Butternut Greenville South Carolina United States 29605
    418 Greenville Health System Cancer Institute-Faris Greenville South Carolina United States 29605
    419 Greenville Memorial Hospital Greenville South Carolina United States 29605
    420 Greenville Health System Cancer Institute/Eastside Greenville South Carolina United States 29615
    421 Greenville Health System Cancer Institute-Greer Greer South Carolina United States 29650
    422 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    423 Lowcountry Hematology Oncology PA-Mount Pleasant Mount Pleasant South Carolina United States 29464
    424 Greenville Health System Cancer Institute-Seneca Seneca South Carolina United States 29672
    425 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    426 Upstate Carolina CCOP Spartanburg South Carolina United States 29303
    427 Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina United States 29307
    428 Rapid City Regional Hospital Rapid City South Dakota United States 57701
    429 Sanford Cancer Center-Oncology Clinic Sioux Falls South Dakota United States 57104
    430 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    431 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    432 Baylor College of Medicine Houston Texas United States 77030
    433 Ben Taub General Hospital Houston Texas United States 77030
    434 Veterans Administration Medical Center Houston Texas United States 77030
    435 Fredericksburg Oncology Inc Fredericksburg Virginia United States 22401
    436 Virginia Commonwealth University Richmond Virginia United States 23298
    437 Cancer Care Center at Island Hospital Anacortes Washington United States 98221
    438 Auburn Regional Medical Center Auburn Washington United States 98001
    439 Overlake Hospital Medical Center Bellevue Washington United States 98004
    440 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    441 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    442 Highline Medical Center-Main Campus Burien Washington United States 98166
    443 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    444 Swedish Medical Center-Edmonds Edmonds Washington United States 98026
    445 Providence Regional Cancer Partnership Everett Washington United States 98201
    446 Saint Francis Hospital Federal Way Washington United States 98003
    447 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    448 Columbia Basin Hematology and Oncology PLLC Kennewick Washington United States 99336
    449 Cascade Cancer Center Kirkland Washington United States 98034
    450 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    451 Saint Clare Hospital Lakewood Washington United States 98499
    452 Saint John Medical Center Longview Washington United States 98632
    453 Skagit Valley Hospital Mount Vernon Washington United States 98274
    454 Providence - Saint Peter Hospital Olympia Washington United States 98506-5166
    455 Capital Medical Center Olympia Washington United States 98507
    456 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
    457 Good Samaritan Community Hospital Puyallup Washington United States 98372
    458 Harborview Medical Center Seattle Washington United States 98104
    459 Minor and James Medical PLLC Seattle Washington United States 98104
    460 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    461 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington United States 98109
    462 Group Health Seattle Washington United States 98109
    463 Group Health Cooperative-Seattle Seattle Washington United States 98112
    464 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    465 The Polyclinic Seattle Washington United States 98122
    466 University of Washington Medical Center Seattle Washington United States 98195
    467 United General Hospital Sedro-Woolley Washington United States 98284
    468 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
    469 Evergreen Hematology and Oncology PS Spokane Washington United States 99218
    470 Rockwood Clinic Spokane Washington United States 99220
    471 Allenmore Hospital Tacoma Washington United States 98405
    472 Northwest CCOP Tacoma Washington United States 98405
    473 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
    474 Saint Joseph Medical Center Tacoma Washington United States 98405
    475 Multicare Health System Tacoma Washington United States 98415
    476 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    477 Compass Oncology Vancouver Vancouver Washington United States 98684
    478 Wenatchee Valley Medical Center Wenatchee Washington United States 98801
    479 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    480 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
    481 Sacred Heart Hospital Eau Claire Wisconsin United States 54701
    482 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
    483 Saint Vincent Hospital Green Bay Wisconsin United States 54301
    484 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
    485 Saint Mary's Hospital Green Bay Wisconsin United States 54303
    486 Gundersen Lutheran La Crosse Wisconsin United States 54601
    487 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    488 Holy Family Memorial Hospital Manitowoc Wisconsin United States 54221
    489 Bay Area Medical Center Marinette Wisconsin United States 54143
    490 Marshfield Clinic Marshfield Wisconsin United States 54449
    491 Saint Joseph's Hospital Marshfield Wisconsin United States 54449
    492 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    493 Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin United States 54154
    494 Marshfield Clinic at James Beck Cancer Center Rhinelander Wisconsin United States 54501
    495 Saint Mary's Hospital Rhinelander Wisconsin United States 54501
    496 Lakeview Medical Center-Marshfield Clinic Rice Lake Wisconsin United States 54868
    497 Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin United States 54868
    498 Saint Nicholas Hospital Sheboygan Wisconsin United States 53081
    499 Marshfield Clinic Cancer Care at Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    500 Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    501 Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
    502 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    503 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    504 Saint Clare's Hospital Weston Wisconsin United States 54476
    505 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    506 Riverview Hospital Wisconsin Rapids Wisconsin United States 54494
    507 Rocky Mountain Oncology Casper Wyoming United States 82609
    508 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Syma Iqbal, MD, University of Southern California

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01498289
    Other Study ID Numbers:
    • S1201
    • S1201
    • U10CA032102
    • NCI-2012-00096
    First Posted:
    Dec 23, 2011
    Last Update Posted:
    Nov 7, 2019
    Last Verified:
    Oct 1, 2019

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 213 participants were randomized, but six were ineligible and 5 were excluded from analysis due to death or withdrawal prior to randomization. Therefore 202 were deemed eligible and analyzable for the primary analysis.
    Arm/Group Title Arm I Arm II
    Arm/Group Description FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
    Period Title: Overall Study
    STARTED 98 104
    Participants Assessed for AEs 91 98
    COMPLETED 0 0
    NOT COMPLETED 98 104

    Baseline Characteristics

    Arm/Group Title Arm I Arm II Total
    Arm/Group Description FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle. Total of all reporting groups
    Overall Participants 98 104 202
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    62.5
    62.4
    62.5
    Sex: Female, Male (Count of Participants)
    Female
    20
    20.4%
    21
    20.2%
    41
    20.3%
    Male
    78
    79.6%
    83
    79.8%
    161
    79.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    12
    12.2%
    19
    18.3%
    31
    15.3%
    Not Hispanic or Latino
    83
    84.7%
    83
    79.8%
    166
    82.2%
    Unknown or Not Reported
    3
    3.1%
    2
    1.9%
    5
    2.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    1%
    0
    0%
    1
    0.5%
    Asian
    5
    5.1%
    8
    7.7%
    13
    6.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    7
    7.1%
    6
    5.8%
    13
    6.4%
    White
    83
    84.7%
    80
    76.9%
    163
    80.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    2
    2%
    10
    9.6%
    12
    5.9%
    ERCC1 (Count of Participants)
    High (>=1.7)
    13
    13.3%
    15
    14.4%
    28
    13.9%
    Low (<1.7)
    85
    86.7%
    89
    85.6%
    174
    86.1%
    Site of Disease (Count of Participants)
    Esophageal
    33
    33.7%
    36
    34.6%
    69
    34.2%
    Gastric/GEJ
    65
    66.3%
    68
    65.4%
    133
    65.8%

    Outcome Measures

    1. Primary Outcome
    Title Progression-free Survival (PFS) in High-ERCC1 Patients
    Description Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.
    Time Frame Up to 3 years after registration

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants with ERCC1 level >= 1.7
    Arm/Group Title Arm I FOLFOX Arm II IT
    Arm/Group Description FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
    Measure Participants 13 15
    Median (95% Confidence Interval) [months]
    4.7
    5.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.83
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Cox Proportional Hazard
    Estimated Value 0.91
    Confidence Interval (2-Sided) 95%
    0.41 to 2.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title PFS in Low-ERCC1 Participants
    Description Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.
    Time Frame Up to 3 years after registration

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants with ERCC1 level < 1.7
    Arm/Group Title Arm I Arm II
    Arm/Group Description FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
    Measure Participants 85 89
    Median (95% Confidence Interval) [months]
    5.9
    2.8
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.68
    Confidence Interval (2-Sided) 95%
    0.50 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    Title Overall Survival (OS)
    Description OS is the length of time between protocol registration and patient death
    Time Frame Up to 3 years after registration

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants
    Arm/Group Title Arm I Arm II
    Arm/Group Description FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
    Measure Participants 98 104
    Median (95% Confidence Interval) [months]
    11.4
    8.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.20
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.82
    Confidence Interval (2-Sided) 95%
    0.61 to 1.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Overall Response Rate (ORR)
    Description ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. 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 3 years after registration

    Outcome Measure Data

    Analysis Population Description
    Participants with measurable disease
    Arm/Group Title Arm I Arm II
    Arm/Group Description FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
    Measure Participants 79 88
    Number (95% Confidence Interval) [percentage of evaluable participants]
    42
    42.9%
    30
    28.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.10
    Comments
    Method Chi-squared
    Comments
    5. Secondary Outcome
    Title PFS Variation by ERCC1
    Description Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first. Participants were divided into subgroups according to ERCC1 quartiles to assess whether the differences in PFS between the two treatment arms varied by ERCC1 levels.
    Time Frame up to 3 years after registration

    Outcome Measure Data

    Analysis Population Description
    Eligible and analyzable participants were divided into quartiles based on ERCC1 levels.
    Arm/Group Title Arm I Arm II
    Arm/Group Description FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium. fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle. leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle. IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
    Measure Participants 98 104
    Q1 ERCC1 (0.20-0.80)
    5.6
    2.8
    Q2 ERCC1 (0.81-1.10)
    7.4
    3.0
    Q3 ERCC1 (1.11-1.42)
    5.6
    2.9
    Q4 ERCC1 (1.43-5.71)
    4.6
    2.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
    Comments Statistical analysis for Q1 ERCC1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.41
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.78
    Confidence Interval (2-Sided) 95%
    0.44 to 1.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
    Comments Statistical analysis for Q2 ERCC1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.06
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.57
    Confidence Interval (2-Sided) 95%
    0.32 to 1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
    Comments Statistical analysis for Q3 ERCC1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.66
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.88
    Confidence Interval (2-Sided) 95%
    0.49 to 1.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
    Comments Statistical analysis for Q4 ERCC1
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.30
    Comments
    Method Regression, Cox
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.74
    Confidence Interval (2-Sided) 95%
    0.42 to 1.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
    Description Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
    Time Frame Duration of treatment and follow up until death or 3 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 Arm I FOLFOX Arm II IT
    Arm/Group Description FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium. IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
    Measure Participants 91 98
    Abdominal pain
    1
    1%
    0
    0%
    Activated partial thromboplastin time prolonged
    0
    0%
    1
    1%
    Acute kidney injury
    0
    0%
    1
    1%
    Alanine aminotransferase increased
    2
    2%
    1
    1%
    Alkaline phosphatase increased
    1
    1%
    1
    1%
    Allergic reaction
    1
    1%
    0
    0%
    Anemia
    6
    6.1%
    14
    13.5%
    Anorexia
    0
    0%
    7
    6.7%
    Aspartate aminotransferase increased
    2
    2%
    5
    4.8%
    Back pain
    0
    0%
    1
    1%
    Bladder infection
    0
    0%
    1
    1%
    Blood bilirubin increased
    1
    1%
    1
    1%
    Bone pain
    1
    1%
    0
    0%
    CD4 lymphocytes decreased
    0
    0%
    3
    2.9%
    Confusion
    1
    1%
    0
    0%
    Death NOS
    1
    1%
    0
    0%
    Dehydration
    2
    2%
    19
    18.3%
    Depression
    1
    1%
    0
    0%
    Diarrhea
    4
    4.1%
    28
    26.9%
    Dry mouth
    1
    1%
    0
    0%
    Dysphagia
    1
    1%
    1
    1%
    Edema limbs
    0
    0%
    1
    1%
    Esophageal hemorrhage
    0
    0%
    1
    1%
    Esophagitis
    0
    0%
    1
    1%
    Fatigue
    7
    7.1%
    14
    13.5%
    Febrile neutropenia
    1
    1%
    6
    5.8%
    Gastrointestinal pain
    0
    0%
    1
    1%
    Generalized muscle weakness
    2
    2%
    2
    1.9%
    Headache
    0
    0%
    1
    1%
    Heart failure
    0
    0%
    1
    1%
    Hyperglycemia
    1
    1%
    1
    1%
    Hypertension
    1
    1%
    1
    1%
    Hypoalbuminemia
    1
    1%
    4
    3.8%
    Hypocalcemia
    0
    0%
    2
    1.9%
    Hypokalemia
    2
    2%
    8
    7.7%
    Hypomagnesemia
    0
    0%
    2
    1.9%
    Hyponatremia
    2
    2%
    5
    4.8%
    Hypotension
    1
    1%
    3
    2.9%
    INR increased
    0
    0%
    1
    1%
    Infections and infestations - Other, specify
    0
    0%
    1
    1%
    Infusion related reaction
    1
    1%
    0
    0%
    Leukocytosis
    0
    0%
    1
    1%
    Lung infection
    1
    1%
    1
    1%
    Lymphocyte count decreased
    9
    9.2%
    7
    6.7%
    Mucositis oral
    2
    2%
    1
    1%
    Multi-organ failure
    0
    0%
    2
    1.9%
    Nausea
    7
    7.1%
    12
    11.5%
    Neutrophil count decreased
    29
    29.6%
    19
    18.3%
    Non-cardiac chest pain
    0
    0%
    1
    1%
    Obstruction gastric
    1
    1%
    0
    0%
    Palmar-plantar erythrodysesthesia syndrome
    1
    1%
    0
    0%
    Peripheral motor neuropathy
    1
    1%
    0
    0%
    Peripheral sensory neuropathy
    10
    10.2%
    1
    1%
    Platelet count decreased
    5
    5.1%
    1
    1%
    Pneumonitis
    0
    0%
    1
    1%
    Respiratory failure
    0
    0%
    2
    1.9%
    Sepsis
    1
    1%
    6
    5.8%
    Stomach pain
    0
    0%
    2
    1.9%
    Syncope
    1
    1%
    2
    1.9%
    Thromboembolic event
    1
    1%
    0
    0%
    Upper gastrointestinal hemorrhage
    0
    0%
    1
    1%
    Urinary tract infection
    0
    0%
    1
    1%
    Vascular access complication
    0
    0%
    1
    1%
    Vomiting
    5
    5.1%
    8
    7.7%
    Weight loss
    0
    0%
    2
    1.9%
    White blood cell decreased
    9
    9.2%
    14
    13.5%

    Adverse Events

    Time Frame Duration of treatment and follow up until death or 3 years post registration
    Adverse Event Reporting Description Population description for all-cause mortality: all eligible and analyzable participants Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs
    Arm/Group Title Arm I FOLFOX Arm II IT
    Arm/Group Description FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium. IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
    All Cause Mortality
    Arm I FOLFOX Arm II IT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 89/98 (90.8%) 94/104 (90.4%)
    Serious Adverse Events
    Arm I FOLFOX Arm II IT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/91 (7.7%) 17/98 (17.3%)
    Gastrointestinal disorders
    Diarrhea 0/91 (0%) 1/98 (1%)
    Mucositis oral 1/91 (1.1%) 0/98 (0%)
    General disorders
    Death NOS 2/91 (2.2%) 4/98 (4.1%)
    Multi-organ failure 0/91 (0%) 2/98 (2%)
    Sudden death NOS 1/91 (1.1%) 0/98 (0%)
    Infections and infestations
    Lung infection 1/91 (1.1%) 0/98 (0%)
    Sepsis 1/91 (1.1%) 6/98 (6.1%)
    Investigations
    Alanine aminotransferase increased 1/91 (1.1%) 0/98 (0%)
    Aspartate aminotransferase increased 1/91 (1.1%) 0/98 (0%)
    Neutrophil count decreased 1/91 (1.1%) 0/98 (0%)
    White blood cell decreased 0/91 (0%) 1/98 (1%)
    Metabolism and nutrition disorders
    Dehydration 0/91 (0%) 1/98 (1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified - Other 0/91 (0%) 5/98 (5.1%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure 0/91 (0%) 2/98 (2%)
    Vascular disorders
    Hypotension 0/91 (0%) 1/98 (1%)
    Thromboembolic event 0/91 (0%) 1/98 (1%)
    Other (Not Including Serious) Adverse Events
    Arm I FOLFOX Arm II IT
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 88/91 (96.7%) 95/98 (96.9%)
    Blood and lymphatic system disorders
    Anemia 65/91 (71.4%) 70/98 (71.4%)
    Febrile neutropenia 1/91 (1.1%) 6/98 (6.1%)
    Leukocytosis 0/91 (0%) 2/98 (2%)
    Lymph node pain 1/91 (1.1%) 0/98 (0%)
    Cardiac disorders
    Atrial fibrillation 1/91 (1.1%) 0/98 (0%)
    Cardiac disorders-Other 1/91 (1.1%) 0/98 (0%)
    Heart failure 0/91 (0%) 1/98 (1%)
    Sinus bradycardia 1/91 (1.1%) 1/98 (1%)
    Sinus tachycardia 2/91 (2.2%) 9/98 (9.2%)
    Ear and labyrinth disorders
    Hearing impaired 2/91 (2.2%) 1/98 (1%)
    Tinnitus 1/91 (1.1%) 0/98 (0%)
    Endocrine disorders
    Endocrine disorders-Other 0/91 (0%) 1/98 (1%)
    Hypothyroidism 0/91 (0%) 1/98 (1%)
    Eye disorders
    Blurred vision 6/91 (6.6%) 4/98 (4.1%)
    Conjunctivitis 1/91 (1.1%) 0/98 (0%)
    Dry eye 2/91 (2.2%) 3/98 (3.1%)
    Eye disorders-Other 0/91 (0%) 3/98 (3.1%)
    Eye pain 2/91 (2.2%) 0/98 (0%)
    Vitreous hemorrhage 0/91 (0%) 1/98 (1%)
    Watering eyes 2/91 (2.2%) 5/98 (5.1%)
    Gastrointestinal disorders
    Abdominal distension 3/91 (3.3%) 3/98 (3.1%)
    Abdominal pain 32/91 (35.2%) 40/98 (40.8%)
    Anal fistula 0/91 (0%) 1/98 (1%)
    Anal hemorrhage 1/91 (1.1%) 0/98 (0%)
    Ascites 5/91 (5.5%) 4/98 (4.1%)
    Bloating 2/91 (2.2%) 5/98 (5.1%)
    Constipation 43/91 (47.3%) 33/98 (33.7%)
    Diarrhea 33/91 (36.3%) 68/98 (69.4%)
    Dry mouth 6/91 (6.6%) 3/98 (3.1%)
    Dyspepsia 6/91 (6.6%) 7/98 (7.1%)
    Dysphagia 25/91 (27.5%) 23/98 (23.5%)
    Esophageal hemorrhage 1/91 (1.1%) 1/98 (1%)
    Esophageal obstruction 1/91 (1.1%) 0/98 (0%)
    Esophageal pain 3/91 (3.3%) 4/98 (4.1%)
    Esophageal stenosis 1/91 (1.1%) 0/98 (0%)
    Esophagitis 1/91 (1.1%) 6/98 (6.1%)
    Fecal incontinence 0/91 (0%) 1/98 (1%)
    Flatulence 7/91 (7.7%) 8/98 (8.2%)
    Gastric fistula 1/91 (1.1%) 0/98 (0%)
    Gastric hemorrhage 0/91 (0%) 1/98 (1%)
    Gastritis 1/91 (1.1%) 1/98 (1%)
    Gastroesophageal reflux disease 8/91 (8.8%) 4/98 (4.1%)
    Gastrointestinal disorders-Other 3/91 (3.3%) 3/98 (3.1%)
    Gastrointestinal pain 2/91 (2.2%) 2/98 (2%)
    Gastroparesis 0/91 (0%) 1/98 (1%)
    Hemorrhoidal hemorrhage 1/91 (1.1%) 0/98 (0%)
    Hemorrhoids 4/91 (4.4%) 1/98 (1%)
    Ileus 0/91 (0%) 2/98 (2%)
    Jejunal stenosis 0/91 (0%) 1/98 (1%)
    Lip pain 1/91 (1.1%) 0/98 (0%)
    Lower gastrointestinal hemorrhage 1/91 (1.1%) 0/98 (0%)
    Malabsorption 0/91 (0%) 1/98 (1%)
    Mucositis oral 30/91 (33%) 9/98 (9.2%)
    Nausea 60/91 (65.9%) 62/98 (63.3%)
    Obstruction gastric 1/91 (1.1%) 1/98 (1%)
    Oral hemorrhage 1/91 (1.1%) 0/98 (0%)
    Oral pain 1/91 (1.1%) 2/98 (2%)
    Rectal hemorrhage 2/91 (2.2%) 0/98 (0%)
    Small intestinal obstruction 1/91 (1.1%) 1/98 (1%)
    Stomach pain 2/91 (2.2%) 4/98 (4.1%)
    Toothache 3/91 (3.3%) 0/98 (0%)
    Upper gastrointestinal hemorrhage 1/91 (1.1%) 2/98 (2%)
    Vomiting 38/91 (41.8%) 44/98 (44.9%)
    General disorders
    Chills 9/91 (9.9%) 5/98 (5.1%)
    Edema face 0/91 (0%) 2/98 (2%)
    Edema limbs 20/91 (22%) 25/98 (25.5%)
    Edema trunk 0/91 (0%) 1/98 (1%)
    Facial pain 3/91 (3.3%) 0/98 (0%)
    Fatigue 74/91 (81.3%) 71/98 (72.4%)
    Fever 6/91 (6.6%) 12/98 (12.2%)
    Flu like symptoms 2/91 (2.2%) 0/98 (0%)
    Gait disturbance 1/91 (1.1%) 1/98 (1%)
    General disorders and admin site conditions - Other 3/91 (3.3%) 0/98 (0%)
    Infusion related reaction 2/91 (2.2%) 2/98 (2%)
    Injection site reaction 0/91 (0%) 1/98 (1%)
    Irritability 1/91 (1.1%) 0/98 (0%)
    Localized edema 0/91 (0%) 2/98 (2%)
    Malaise 1/91 (1.1%) 2/98 (2%)
    Non-cardiac chest pain 5/91 (5.5%) 6/98 (6.1%)
    Pain 8/91 (8.8%) 6/98 (6.1%)
    Hepatobiliary disorders
    Gallbladder pain 0/91 (0%) 1/98 (1%)
    Portal vein thrombosis 0/91 (0%) 1/98 (1%)
    Immune system disorders
    Allergic reaction 6/91 (6.6%) 3/98 (3.1%)
    Infections and infestations
    Bladder infection 0/91 (0%) 2/98 (2%)
    Bronchial infection 1/91 (1.1%) 0/98 (0%)
    Enterocolitis infectious 0/91 (0%) 1/98 (1%)
    Eye infection 0/91 (0%) 1/98 (1%)
    Infections and infestations-Other 2/91 (2.2%) 4/98 (4.1%)
    Lip infection 0/91 (0%) 1/98 (1%)
    Lung infection 0/91 (0%) 2/98 (2%)
    Lymph gland infection 1/91 (1.1%) 0/98 (0%)
    Mucosal infection 1/91 (1.1%) 2/98 (2%)
    Otitis media 0/91 (0%) 1/98 (1%)
    Peritoneal infection 0/91 (0%) 1/98 (1%)
    Rhinitis infective 1/91 (1.1%) 1/98 (1%)
    Sepsis 1/91 (1.1%) 1/98 (1%)
    Sinusitis 3/91 (3.3%) 0/98 (0%)
    Skin infection 3/91 (3.3%) 4/98 (4.1%)
    Tooth infection 0/91 (0%) 3/98 (3.1%)
    Tracheitis 0/91 (0%) 1/98 (1%)
    Upper respiratory infection 5/91 (5.5%) 5/98 (5.1%)
    Urinary tract infection 0/91 (0%) 1/98 (1%)
    Vaginal infection 1/91 (1.1%) 0/98 (0%)
    Wound infection 0/91 (0%) 1/98 (1%)
    Injury, poisoning and procedural complications
    Bruising 3/91 (3.3%) 0/98 (0%)
    Burn 1/91 (1.1%) 0/98 (0%)
    Fall 2/91 (2.2%) 3/98 (3.1%)
    Fracture 1/91 (1.1%) 0/98 (0%)
    Injury, poison and procedural complications - Other 1/91 (1.1%) 0/98 (0%)
    Vascular access complication 0/91 (0%) 1/98 (1%)
    Investigations
    Activated partial thromboplastin time prolonged 0/91 (0%) 2/98 (2%)
    Alanine aminotransferase increased 19/91 (20.9%) 20/98 (20.4%)
    Alkaline phosphatase increased 39/91 (42.9%) 31/98 (31.6%)
    Aspartate aminotransferase increased 26/91 (28.6%) 28/98 (28.6%)
    Blood bilirubin increased 13/91 (14.3%) 10/98 (10.2%)
    CD4 lymphocytes decreased 4/91 (4.4%) 7/98 (7.1%)
    Cholesterol high 2/91 (2.2%) 2/98 (2%)
    Creatinine increased 2/91 (2.2%) 13/98 (13.3%)
    Ejection fraction decreased 0/91 (0%) 1/98 (1%)
    INR increased 1/91 (1.1%) 3/98 (3.1%)
    Investigations-Other 0/91 (0%) 2/98 (2%)
    Lipase increased 0/91 (0%) 2/98 (2%)
    Lymphocyte count decreased 27/91 (29.7%) 26/98 (26.5%)
    Neutrophil count decreased 47/91 (51.6%) 30/98 (30.6%)
    Platelet count decreased 50/91 (54.9%) 12/98 (12.2%)
    Serum amylase increased 0/91 (0%) 1/98 (1%)
    Weight gain 5/91 (5.5%) 2/98 (2%)
    Weight loss 37/91 (40.7%) 32/98 (32.7%)
    White blood cell decreased 50/91 (54.9%) 41/98 (41.8%)
    Metabolism and nutrition disorders
    Anorexia 40/91 (44%) 46/98 (46.9%)
    Dehydration 13/91 (14.3%) 35/98 (35.7%)
    Glucose intolerance 0/91 (0%) 3/98 (3.1%)
    Hypercalcemia 1/91 (1.1%) 2/98 (2%)
    Hyperglycemia 42/91 (46.2%) 36/98 (36.7%)
    Hyperkalemia 3/91 (3.3%) 7/98 (7.1%)
    Hypermagnesemia 1/91 (1.1%) 1/98 (1%)
    Hypernatremia 2/91 (2.2%) 4/98 (4.1%)
    Hypertriglyceridemia 1/91 (1.1%) 0/98 (0%)
    Hyperuricemia 1/91 (1.1%) 0/98 (0%)
    Hypoalbuminemia 44/91 (48.4%) 51/98 (52%)
    Hypocalcemia 30/91 (33%) 34/98 (34.7%)
    Hypoglycemia 5/91 (5.5%) 4/98 (4.1%)
    Hypokalemia 20/91 (22%) 31/98 (31.6%)
    Hypomagnesemia 6/91 (6.6%) 9/98 (9.2%)
    Hyponatremia 21/91 (23.1%) 35/98 (35.7%)
    Hypophosphatemia 2/91 (2.2%) 4/98 (4.1%)
    Metabolism and nutrition disorders - Other, specify 3/91 (3.3%) 3/98 (3.1%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 7/91 (7.7%) 12/98 (12.2%)
    Back pain 13/91 (14.3%) 12/98 (12.2%)
    Bone pain 3/91 (3.3%) 3/98 (3.1%)
    Buttock pain 1/91 (1.1%) 1/98 (1%)
    Chest wall pain 3/91 (3.3%) 1/98 (1%)
    Flank pain 1/91 (1.1%) 0/98 (0%)
    Generalized muscle weakness 9/91 (9.9%) 17/98 (17.3%)
    Joint effusion 0/91 (0%) 1/98 (1%)
    Muscle weakness lower limb 0/91 (0%) 2/98 (2%)
    Muscle weakness upper limb 0/91 (0%) 1/98 (1%)
    Musculoskeletal and connective tiss disorder - Other 5/91 (5.5%) 1/98 (1%)
    Myalgia 7/91 (7.7%) 5/98 (5.1%)
    Neck pain 4/91 (4.4%) 1/98 (1%)
    Pain in extremity 12/91 (13.2%) 6/98 (6.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified - Other 1/91 (1.1%) 1/98 (1%)
    Tumor pain 0/91 (0%) 1/98 (1%)
    Nervous system disorders
    Ataxia 1/91 (1.1%) 2/98 (2%)
    Cognitive disturbance 1/91 (1.1%) 1/98 (1%)
    Depressed level of consciousness 0/91 (0%) 1/98 (1%)
    Dizziness 16/91 (17.6%) 20/98 (20.4%)
    Dysesthesia 1/91 (1.1%) 0/98 (0%)
    Dysgeusia 19/91 (20.9%) 19/98 (19.4%)
    Dysphasia 1/91 (1.1%) 2/98 (2%)
    Extrapyramidal disorder 1/91 (1.1%) 0/98 (0%)
    Headache 11/91 (12.1%) 9/98 (9.2%)
    Hypersomnia 0/91 (0%) 1/98 (1%)
    Ischemia cerebrovascular 1/91 (1.1%) 0/98 (0%)
    Memory impairment 0/91 (0%) 2/98 (2%)
    Nervous system disorders-Other 3/91 (3.3%) 0/98 (0%)
    Paresthesia 18/91 (19.8%) 3/98 (3.1%)
    Peripheral motor neuropathy 4/91 (4.4%) 1/98 (1%)
    Peripheral sensory neuropathy 57/91 (62.6%) 18/98 (18.4%)
    Sinus pain 0/91 (0%) 2/98 (2%)
    Stroke 1/91 (1.1%) 0/98 (0%)
    Syncope 4/91 (4.4%) 4/98 (4.1%)
    Tremor 1/91 (1.1%) 2/98 (2%)
    Psychiatric disorders
    Anxiety 15/91 (16.5%) 16/98 (16.3%)
    Confusion 3/91 (3.3%) 2/98 (2%)
    Delirium 1/91 (1.1%) 0/98 (0%)
    Depression 15/91 (16.5%) 9/98 (9.2%)
    Hallucinations 1/91 (1.1%) 0/98 (0%)
    Insomnia 14/91 (15.4%) 13/98 (13.3%)
    Libido decreased 1/91 (1.1%) 0/98 (0%)
    Personality change 1/91 (1.1%) 0/98 (0%)
    Psychiatric disorders-Other 1/91 (1.1%) 0/98 (0%)
    Suicidal ideation 1/91 (1.1%) 0/98 (0%)
    Renal and urinary disorders
    Acute kidney injury 2/91 (2.2%) 3/98 (3.1%)
    Chronic kidney disease 2/91 (2.2%) 3/98 (3.1%)
    Hematuria 2/91 (2.2%) 0/98 (0%)
    Proteinuria 0/91 (0%) 2/98 (2%)
    Renal calculi 1/91 (1.1%) 0/98 (0%)
    Urinary frequency 2/91 (2.2%) 3/98 (3.1%)
    Urinary retention 2/91 (2.2%) 2/98 (2%)
    Reproductive system and breast disorders
    Irregular menstruation 1/91 (1.1%) 0/98 (0%)
    Nipple deformity 0/91 (0%) 1/98 (1%)
    Testicular pain 0/91 (0%) 1/98 (1%)
    Vaginal hemorrhage 1/91 (1.1%) 0/98 (0%)
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis 5/91 (5.5%) 6/98 (6.1%)
    Aspiration 2/91 (2.2%) 1/98 (1%)
    Atelectasis 0/91 (0%) 1/98 (1%)
    Bronchopulmonary hemorrhage 1/91 (1.1%) 1/98 (1%)
    Cough 20/91 (22%) 21/98 (21.4%)
    Dyspnea 16/91 (17.6%) 20/98 (20.4%)
    Epistaxis 11/91 (12.1%) 5/98 (5.1%)
    Hiccups 4/91 (4.4%) 7/98 (7.1%)
    Hoarseness 1/91 (1.1%) 1/98 (1%)
    Hypoxia 1/91 (1.1%) 2/98 (2%)
    Laryngopharyngeal dysesthesia 3/91 (3.3%) 0/98 (0%)
    Nasal congestion 5/91 (5.5%) 2/98 (2%)
    Pharyngeal mucositis 0/91 (0%) 1/98 (1%)
    Pharyngolaryngeal pain 1/91 (1.1%) 0/98 (0%)
    Pleural effusion 2/91 (2.2%) 6/98 (6.1%)
    Pleuritic pain 0/91 (0%) 1/98 (1%)
    Pneumonitis 0/91 (0%) 1/98 (1%)
    Postnasal drip 2/91 (2.2%) 1/98 (1%)
    Productive cough 4/91 (4.4%) 4/98 (4.1%)
    Resp, thoracic and mediastinal disorders - Other 5/91 (5.5%) 1/98 (1%)
    Respiratory failure 0/91 (0%) 1/98 (1%)
    Sinus disorder 1/91 (1.1%) 1/98 (1%)
    Sneezing 1/91 (1.1%) 0/98 (0%)
    Sore throat 5/91 (5.5%) 3/98 (3.1%)
    Voice alteration 1/91 (1.1%) 3/98 (3.1%)
    Wheezing 1/91 (1.1%) 1/98 (1%)
    Skin and subcutaneous tissue disorders
    Alopecia 10/91 (11%) 30/98 (30.6%)
    Dry skin 11/91 (12.1%) 10/98 (10.2%)
    Hyperhidrosis 2/91 (2.2%) 5/98 (5.1%)
    Nail discoloration 0/91 (0%) 4/98 (4.1%)
    Nail loss 0/91 (0%) 2/98 (2%)
    Nail ridging 0/91 (0%) 4/98 (4.1%)
    Pain of skin 0/91 (0%) 1/98 (1%)
    Palmar-plantar erythrodysesthesia syndrome 8/91 (8.8%) 2/98 (2%)
    Pruritus 5/91 (5.5%) 6/98 (6.1%)
    Rash acneiform 1/91 (1.1%) 5/98 (5.1%)
    Rash maculo-papular 7/91 (7.7%) 7/98 (7.1%)
    Skin and subcutaneous tissue disorders - Other 5/91 (5.5%) 0/98 (0%)
    Skin hyperpigmentation 4/91 (4.4%) 0/98 (0%)
    Skin ulceration 1/91 (1.1%) 1/98 (1%)
    Urticaria 0/91 (0%) 1/98 (1%)
    Vascular disorders
    Flushing 0/91 (0%) 1/98 (1%)
    Hematoma 0/91 (0%) 1/98 (1%)
    Hot flashes 5/91 (5.5%) 2/98 (2%)
    Hypertension 18/91 (19.8%) 15/98 (15.3%)
    Hypotension 7/91 (7.7%) 19/98 (19.4%)
    Thromboembolic event 10/91 (11%) 7/98 (7.1%)
    Vascular disorders-Other 0/91 (0%) 1/98 (1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title SWOG Statistician
    Organization SWOG Statistics and Data Management Center
    Phone 2066674623
    Email mduong@fredhutch.org
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01498289
    Other Study ID Numbers:
    • S1201
    • S1201
    • U10CA032102
    • NCI-2012-00096
    First Posted:
    Dec 23, 2011
    Last Update Posted:
    Nov 7, 2019
    Last Verified:
    Oct 1, 2019