Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0) No metastatic cancer to the ovaries Age: 18 and over Easter Cooperative Oncology Group (ECOG) performance status 0-2 White blood cell (WBC) count at least 4,000 cells/mm3 Platelet count at least 150,000/mm3 Bilirubin less than 2 mg/dL Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 50 mL/min Caloric intake must be at least 1500 kcal/day No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix No prior radiation therapy, except for skin cancer Fertile patients must use adequate contraception Met criteria for re-registration after surgery T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration. No evidence of metastatic disease from postoperative pathologic staging. ECOG performance status of 0, 1, or 2 at re-registration Curative resection performed Re-registered 4 - 6 weeks from the date of surgery WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration Exclusion Criteria: Prior chemotherapy Clinically significant auditory impairment Significant heart disease Pregnant or lactating
Sites / Locations
- CCOP - Colorado Cancer Research Program, Inc.
- Emory University Hospital - Atlanta
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Veterans Affairs Medical Center - Lakeside Chicago
- CCOP - Evanston
- CCOP - Carle Cancer Center
- Indiana University Cancer Center
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- CCOP - Cedar Rapids Oncology Project
- CCOP - Ochsner
- New England Medical Center Hospital
- CCOP - Ann Arbor Regional
- CCOP - Kalamazoo
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Morristown Memorial Hospital
- Cancer Institute of New Jersey
- Raritan Bay Medical Center
- Somerset Medical Center
- Albert Einstein Comprehensive Cancer Center
- University of Rochester Cancer Center
- Ireland Cancer Center
- CCOP - Toledo Community Hospital Oncology Program
- University of Pennsylvania Cancer Center
- CCOP - MainLine Health
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
- Vanderbilt-Ingram Cancer Center
- CCOP - Marshfield Medical Research and Education Foundation
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
Arms of the Study
Arm 1
Experimental
Experimental Arm
Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.