Randomized Phase III Study of Preoperative Chemotherapy Followed by Surgery Versus Surgery Alone in Locally Advanced Gastric Cancer (cT3 and cT4NxM0)

Date de début de l'étude : 1 juillet 1999

DISEASE CHARACTERISTICS: Histologically proven stage II-IV adenocarcinoma of the stomach including cardia carcinoma types II and III Locally resectable disease No distant metastases except M1 lymph nodes No evidence of peritoneal carcinomatosis Free tumor cells in lavage at laparoscopy allowed No uncontrolled bleeding of the primary tumor No gastric outlet syndrome or complete tumor stenosis that would require total parenteral nutrition PATIENT CHARACTERISTICS: Age: 18 to 69 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Absolute neutrophil count greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) Prothrombin rate at least 70% Renal: Creatinine no greater than 1.25 times ULN Creatinine clearance greater than 60 mL/min Cardiovascular: No prior atrial or ventricular arrhythmias No prior congestive heart failure No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior or concurrent neoplasm except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No active infection No allergy to protocol drugs No dementia or significantly altered mental status No other serious medical condition that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No filgrastim (G-CSF) within 48 hours prior to chemotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No prior stent implantation No prior laser therapy