RATIONALE: Drugs used in chemotherapy 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. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer.
PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.
Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to depth of tumor penetration (T1 or T2 vs T3 vs T4), lymph node involvement (0 vs 1-3), and extent of lymphadenectomy (D1 or D2 vs D0 or unknown). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 824 patients will be accrued for this study.
Esophageal Cancer Gastric Cancer stage I gastric cancer stage II gastric cancer stage III gastric cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer Cisplatin Fluorouracil Epirubicin Levoleucovorin Leucovorin
For people ages 18 years and up
Required Tumor Parameters
1.1 Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.
1.2 Patients must have had en bloc resection of all known tumor. The surgical resection must have been done with a curative intent.
1.3 Patients must have tumor extension beyond muscularis propria and/or nodal involvement without evidence of M1 disease.
1.4 Patients with known unresected cancer, recurrent cancer, microscopic evidence of tumor at the distal or proximal line of stomach resection, noncontiguous resection of tumor, or M1 (metastatic) disease are ineligible.
2.1 No prior therapy (except hormonal or biologic) for other malignancies is allowed except for adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years.
2.2 Patients who have had any previous chemotherapy or radiotherapy are ineligible.
3.1 Patients must have an ECOG (CTC) performance status of 0, 1 or 2.
3.2 Patients are required to have an adequate total caloric intake to allow them to maintain their post-surgical body weight. Patients must have documentation of stable weight (or less than 2 pounds weight loss) for at least one week prior to registration.
3.3 All patients must be evaluated by a radiation oncologist (prior to enrollment) to ensure that the patient is an appropriate candidate for radiation therapy.
3.4 Patients may not have unilateral renal function (only one functioning kidney) as determined by CT scan with contrast, urogram, renal scan, or other study.
3.5 Pregnant or lactating women may not participate. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method or practice abstinence while in this study.
3.6 Patients with any of the following cardiac conditions are ineligible:
3.7 No uncontrolled serious medical or psychiatric illness which would prevent compliance with treatment or adequate informed consent.
3.8 Patients with active infectious process are ineligible.
3.9 Patients with grade 2 or greater peripheral neuropathy at baseline are ineligible.
Required Initial Laboratory Values:
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