Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring stage II gastric cancer, stage III gastric cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced gastric carcinoma that is considered operable T3-4, Nx, M0 OR Tx, N+, M0 Lymph nodes considered positive by sonography should be at least 2 of the following: Round Echopoor Sharp borders At least 0.5 cm No distant metastases, including peritoneal carcinomatosis CT scan and peritoneal lavage mandatory PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Adequate renal function within limits to allow for treatment with cisplatin Cardiovascular: No unstable cardiac disease requiring treatment No congestive heart failure or angina pectoris even if medically controlled No significant arrhythmias No myocardial infarction within past 6 months Ejection fraction greater than 50% on cardiac sonography or MUGA scan Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic) No history of anaphylaxis No other serious concurrent illness or medical condition that would preclude study therapy No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy for gastric carcinoma Chemotherapy: No other concurrent chemotherapy for gastric carcinoma Endocrine therapy: No concurrent endocrine therapy for gastric carcinoma Radiotherapy: No concurrent radiotherapy for gastric carcinoma Surgery: See Disease Characteristics Other: At least 30 days since prior treatment in a clinical trial No other concurrent experimental drugs No other concurrent anticancer therapy
Sites / Locations
- European Institute of Oncology
- Hopital Cantonal Universitaire de Geneve
- Zentrum fuer Tumordiagnostikund Praevention
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Taxotere-Cisplatin-5FU preoperatively
Immediate surgery followed by TCF
TCF preoperatively
Surgery followed by Taxotere-Cisplatin-5FU