PURPOSE: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in @entity356 , a multicenter phase III clinical trial was conducted in Japan. @entity1 AND METHODS: From January 1993 to March 1998, 268 @entity1 were randomized to adjuvant chemotherapy (135 @entity1 ) or surgery alone (133 @entity1 ). All @entity1 underwent gastrectomy with D2 or greater lymph node dissection. The chemotherapy regimen consisted of intraperitoneal @entity900 soon after abdominal closure, postoperative intravenous @entity900 (day 14) and @entity1487 (day 14-16), and daily oral FU (UFT) starting 4 weeks after surgery for 12 months. The primary endpoint was overall survival. Relapse-free survival and site of recurrence were secondary endpoints. RESULTS: Fifty-two @entity1 (38.5%) in the adjuvant chemotherapy arm completed the chemotherapy regimen. There were 4 (1.49%) treatment-related deaths, 1 in the surgery-alone and 3 in the adjuvant chemotherapy arm (2 did not receive chemotherapy). Grade 4 @entity137 was observed in 3 @entity1 in the surgery-alone and 2 @entity1 in the adjuvant chemotherapy arm. There was no significant difference in 5-year overall survival (62.0% adjuvant chemotherapy vs. 60.9% surgery-alone, P = 0.482) and 5-year relapse-free survival rates (57.5% adjuvant chemotherapy vs. 55.6% surgery-alone; P = 0.512). CONCLUSION: There was no benefit in overall and relapse-free survival with this adjuvant chemotherapy regimen for @entity1 with macroscopically @entity356 after curative resection.

Randomized clinical trial of adjuvant chemotherapy with intraperitoneal and intravenous @entity900 followed by oral @entity1487 (UFT) in XXXX versus curative resection alone: final results of the Japan Clinical Oncology Group trial JCOG9206-2.

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity356 :: ('MESH:D013274', 'Disease') :: ['serosa-positive gastric cancer'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5-fluorouracil']
@entity356 :: (MESH:D013274,Disease) :: ['serosa-positive gastric cancer']
