Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)

INTERVENTION: A: Best available 5‐FU In the best available 5‐FU arm, 5‐FU continuous infusion (5‐FUci) regimen or sequential methotrexate (MTX) and 5‐fluorouracil (MTX/5‐FU) regimen is selected according to patients' prior chemotherapy: If the prior chemotherapy included 5‐FU bolus infusion or MTX, 5‐FUci regimen will be selected. The other cases select MTX/5‐FU regimen. The 5‐FUci regimen consists of 5‐FUci (800 mg/m2/day, days 1 through 5), every 4 weeks. The MTX/5‐FU regimen consists of MTX bolus infusion (100 mg/m2/day, day 1), 5‐FU bolus infusion (600 mg/m2/day, day 1) after MTX, and l‐leucovorin administration by oral or infusion (10 mg/m2/6 hour, days 2 through 3), which are repeated weekly. B: Low dose paclitaxel The low‐dose paclitaxel regimen consists of 1‐hour paclitaxel infusion (80 mg/m2/day, days 1, 8, and 15) every 4 weeks. CONDITION: gastric neoplasm PRIMARY OUTCOME: overall survival SECONDARY OUTCOME: adverse events INCLUSION CRITERIA: (1) they have histologically proven recurrence or unresectable gastric adenocarcionoma (2) they have peritoneal metastasis (3) they have no symptomatic central nerve system metastasis (4) they are aged 20‐75 years (5) they have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (6) In recurred cases, they had received fluoropirimidine analogs containing regimen as adjuvant chemotherapy. The period from last administration of adjuvant chemotherapy should be within 24 days. In unresectable cases, they had received fluoropirimidine analogs containing regimen as 1st line chemotherapy. The period from last administration of 1st line chemotherapy should be within 6 weeks. The fluoropirimidine analogs containing regimen is as follows: fluorouracil (5‐FU), uracil and tegafur (UFT), tegafur, gimeracil, oteracil potassium (TS‐1), 1‐hexylcarbamoyl‐5‐fluorouracil (HCFJ), tegafur, 5'‐DFUR;doxifluridine (FT) (7) their prior chemotherapy