S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
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 |
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Phase 2 |
Detailed Description
OBJECTIVES:
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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.
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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.
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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.
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To assess overall survival of and toxicities in each of the two treatment arms in this group of patients.
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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.
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To explore whether there is evidence of interaction between treatment arm and ERCC1 expression in this group of patients. (Exploratory)
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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.
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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.
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
Drug: leucovorin calcium
400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
Other Names:
Drug: oxaliplatin
85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
Other Names:
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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:
Drug: irinotecan hydrochloride
65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- Overall Survival (OS) [Up to 3 years after registration]
OS is the length of time between protocol registration and patient death
Secondary Outcome Measures
- 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.
- 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.
- 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
DISEASE CHARACTERISTICS:
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Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)
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Patients must not have received treatment for metastatic or unresectable disease
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Patients must not have brain metastases
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Patients must have measurable and/or non-measurable disease
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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
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Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration
PATIENT CHARACTERISTICS:
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Zubrod performance status of 0-1
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Hemoglobin ≥ 9 g/dL
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Absolute neutrophil count (ANC) ≥ 1,500/mcL
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Platelets ≥ 100,000/mcL
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Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor
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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
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Serum creatinine < 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance > 60 mL/min
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Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0
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Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
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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:
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See Disease Characteristics
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All palliative radiation therapy alone must be completed at least 14 days prior to registration
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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 | |
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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.- S1201
- S1201
- U10CA032102
- NCI-2012-00096
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
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 |
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 |
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 |
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 |
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 |
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
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 |
mduong@fredhutch.org |
- S1201
- S1201
- U10CA032102
- NCI-2012-00096