Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery
Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery
RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel use different ways to
 stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
 high-energy x-rays to damage tumor cells. Cisplatin and paclitaxel may make the tumor cells
 more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.

 PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and
 radiation therapy with or without fluorouracil in treating patients who have stage IB, stage
 IIB, or stage IIIB stomach cancer that has been removed during surgery.
OBJECTIVES:

 -  Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric
 cancer treated with cisplatin, paclitaxel, and radiotherapy with or without fluorouracil
 vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 (RTOG 90-18).
 (Arm I closed to accrual as of 6/18/03.)

 -  Compare the safety and success of these regimens vs therapy in the intergroup adjuvant
 study.

 -  Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the
 intergroup study.

 OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
 stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more).
 Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of
 6/18/03.)

 -  Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously
 and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on
 days 1 and 29.

 At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and
 fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also
 receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.

 -  Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days
 1 and 29.

 At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and
 paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive
 cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.

 Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
 annually thereafter.

 PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or
 gastroesophageal junction having undergone potentially curative resection of primary
 tumor

 -  No more than 8 weeks since primary tumor resection

 -  No metastatic disease

 PATIENT CHARACTERISTICS:

 Age:

 -  Not specified

 Performance status:

 -  Zubrod 0-1

 Life expectancy:

 -  Not specified

 Hematopoietic:

 -  WBC (white blood cell count) at least 4,000/mm^3

 -  Platelet count at least 150,000/mm^3

 Hepatic:

 -  Bilirubin no greater than 1.5 mg/dL

 -  AST (aspartate aminotransferase) and ALT (alanine amino transferase) no greater than
 2.5 times upper limit of normal

 Renal:

 -  BUN(blood urea nitrogen)less than 30 mg/dL

 -  Creatinine no greater than 1.4 mg/dL

 -  Creatinine clearance greater than 50 mL/min

 Cardiovascular:

 -  No New York Heart Association class III or IV heart disease

 -  No active angina or myocardial infarction within the past 6 months

 -  No history of significant ventricular arrhythmia requiring medication with
 antiarrhythmics

 -  No history of clinically significant conduction system abnormality

 Other:

 -  No concurrent serious infection that is uncontrolled or would preclude study
 participation

 -  No nonmalignant medical illness that is uncontrolled or would preclude study
 participation

 -  No psychiatric disorders that would preclude study participation

 -  No other active malignancy within the past 3 years except nonmelanoma skin cancer or
 carcinoma in situ of the cervix

 -  No clinically significant hearing loss

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  Not specified

 Chemotherapy:

 -  No prior chemotherapy

 -  No other concurrent chemotherapy

 Endocrine therapy:

 -  Not specified

 Radiotherapy:

 -  No prior radiotherapy to the treatment field

 Surgery:

 -  See Disease Characteristics

 Other:

 -  No other concurrent anticancer therapy