S0425 Oxaliplatin, Capecitabine, and RT in Treating Patients W/Stomach Cancer That Can Be Removed By Surgery
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring adenocarcinoma of the stomach, stage I gastric cancer, stage II gastric cancer, stage III gastric cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary adenocarcinoma of the stomach, meeting the following criteria: Newly diagnosed disease amenable to curative resection Stage IB-III (T2-4) Measurable or nonmeasurable disease Enlarged lymph nodes outside of radiation fields must have preoperative biopsies No positive lymph nodes outside of radiation fields No distant metastasis No gastroesophageal junction tumors PATIENT CHARACTERISTICS: Zubrod performance status 0-1 Absolute neutrophil count ≥ 1,500/mm³ WBC ≥ 3,000/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times upper limit of normal Albumin ≥ 3 g/dL Bilirubin normal No evidence of ischemic heart disease by EKG No coronary artery disease requiring active medical treatment No symptoms of angina No history of myocardial infarction No deep vein thrombosis within the past 12 months No pre-existing peripheral neuropathy No active pneumonia or inflammatory lung infiltrate No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥ 5 years No clinically significant comorbid medical conditions that would prevent delivery of chemotherapy, radiotherapy, or the performance of surgery Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: At least 4 weeks since prior and no concurrent sorivudine or brivudine No prior therapy for this malignancy, including chemotherapy, surgery, immunotherapy, or radiotherapy No prior coronary angioplasty or stenting No concurrent 2-dimensional or intensity-modulated radiotherapy
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Providence Saint Joseph Medical Center - Burbank
- USC/Norris Comprehensive Cancer Center and Hospital
- Desert Regional Medical Center Comprehensive Cancer Center
- University of Colorado Cancer Center at UC Health Sciences Center
- Veterans Affairs Medical Center - Denver
- Shaw Regional Cancer Center
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services
- Tammy Walker Cancer Center at Salina Regional Health Center
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Metro Health Hospital
- Holland Community Hospital
- Hackley Hospital
- Munson Medical Center
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Wayne Memorial Hospital, Incorporated
- Charles M. Barrett Cancer Center at University Hospital
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Hollings Cancer Center at Medical University of South Carolina
- Medical City Dallas Hospital
- Danville Regional Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Chemotherapy, Chemoradiation, Surgery
Chemotherapy: Oxaliplatin, 130 mg/m2, 2 hour IV infusion on Days 1 and 22; Capecitabine 850 mg/m2/dose, PO q 12 hours on Days 1-14 and 22-35 Chemoradiation: Capecitabine 650 mg/m2/dose, PO q 12 hours on days 43-77; Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Surgery: Distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy