Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
(adenocarcinoma of the esophagus must involve the gastroesophageal junction) meeting
the following criteria:

- Tumor extension beyond muscularis propria and/or nodal involvement without
evidence of M1 disease

- Stage II, IIIA, IIIB, or IV (T2, N2, M0)

- Stage IB (T1, N1, M0; T2, N0, M0 allowed if extension beyond muscularis propia)

- Prior en bloc resection, with curative intent, of all known tumor

- No microscopic evidence of tumor at the line of resection

- No noncontiguous resection

- No known unresected or recurrent disease at the distal or proximal line of stomach
resection

- No metastatic disease

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 2.0 mg/dL

- AST no greater than 3 times upper limit of normal

Renal

- Creatinine no greater than 1.5 mg/dL

- No unilateral renal function

Cardiovascular

- No myocardial infarction within the past 6 months

- No uncontrolled high blood pressure

- No unstable angina

- No symptomatic congestive heart failure

- No serious uncontrolled cardiac arrhythmia

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

- No cardiac disease resulting in marked limitation or inability of physical activity

Other

- Stable weight for at least one week before study

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or fully resected noninvasive carcinoma in situ

- No other uncontrolled serious medical condition or psychiatric illness that would
preclude study entry

- No active infection

- No peripheral neuropathy grade 2 or greater

- All patients must be evaluated by a radiation oncologist prior to enrollment to
ensure patient is appropriate for radiotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior biologic therapy allowed

Chemotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Prior hormonal therapy allowed

- No concurrent hormonal therapy except the following:

- Steroids for adrenal failure

- Hormones for non-disease-related conditions (e.g., insulin for diabetes)

- Intermittent dexamethasone as an antiemetic

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

- At least 3 weeks since prior surgery

- No more than 12 weeks since prior surgery