chemotherapy and radiation therapy in treating patients with stomach cancer

Conditions: Gastric Cancer

Summary: 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 may kill more tumor cells. purpose: phase ii trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.

objectives: * determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach. * determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen. * determine the tolerability of this regimen in these patients. outline: patients receive fluorouracil iv over 24 hours on days 1-21, cisplatin iv over 1 hour on days 1-5, and leucovorin calcium iv over 15 minutes on days 1, 8, 15, and 22. a second course is administered beginning on day 29. chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). patients receive fluorouracil iv over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel iv over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29. approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection. patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter. projected accrual: a total of 21-49 patients will be accrued for this study within 2.5 years.

Eligibility criteria:
disease characteristics: * histologically proven adenocarcinoma of the stomach * stage ib, ii, iiia, iiib, and iv (t2-3, any n, m0) * no lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes) * potentially resectable * may involve the gastroesophageal junction, but bulk of tumor must be in the stomach * no distant metastases * no pleural or pericardial effusion * no peritoneal disease diagnosed by laparoscopy patient characteristics: age: * not specified performance status: * zubrod 0-2 life expectancy: * at least 16 weeks hematopoietic: * absolute granulocyte count greater than 2,000/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 mg/dl renal: * creatinine less than 1.5 mg/dl cardiovascular: * no new york heart association class iii or iv heart disease * no hypertension neurologic: * no cerebrovascular disease * no diabetic neuropathy * no mental status abnormalities other: * no uncontrolled diabetes * no infection * no other malignancies within past 5 years except resected squamous cell or basal cell skin cancer * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no prior immunotherapy chemotherapy: * no prior chemotherapy endocrine therapy: * not specified radiotherapy: * no prior radiotherapy to stomach surgery: * no prior surgery to stomach

Keywords: stage i gastric cancer stage ii gastric cancer stage iii gastric cancer stage iv gastric cancer adenocarcinoma of the stomach