A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer

Date de début de l'étude : 1 juin 1999

Inclusion Criteria: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0) No metastatic cancer to the ovaries Age: 18 and over Easter Cooperative Oncology Group (ECOG) performance status 0-2 White blood cell (WBC) count at least 4,000 cells/mm3 Platelet count at least 150,000/mm3 Bilirubin less than 2 mg/dL Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 50 mL/min Caloric intake must be at least 1500 kcal/day No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix No prior radiation therapy, except for skin cancer Fertile patients must use adequate contraception Met criteria for re-registration after surgery T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration. No evidence of metastatic disease from postoperative pathologic staging. ECOG performance status of 0, 1, or 2 at re-registration Curative resection performed Re-registered 4 - 6 weeks from the date of surgery WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration Exclusion Criteria: Prior chemotherapy Clinically significant auditory impairment Significant heart disease Pregnant or lactating