Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone 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