PURPOSE: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative @entity356 @entity1 (excluding @entity1 who were T1N0), we conducted a multicenter phase III clinical trial in which 13 @entity5 centers in Japan participated. @entity1 AND METHODS: From January 1993 to December 1994, 252 @entity1 were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m2, @entity1487 (FU) 166.7 mg/m2, and @entity2592 13.3 mg/m2 twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m2 daily for the next 18 months for a total dose of 67 g/m2. The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points. RESULTS: Ninety-eight percent of @entity1 underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related @entity204 and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P =.14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P =.13, respectively). Nine @entity1 (7.1%) in the chemotherapy arm and 17 @entity1 (13.8%) in the surgery-alone arm had @entity5 recurrence. CONCLUSION: There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for @entity1 with macroscopically serosa-negative @entity356 after curative resection, and there was no statistical difference between the two arms relating to the types of @entity5 recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.

Randomized trial of adjuvant chemotherapy with mitomycin, @entity1487 , and @entity2592 followed by oral XXXX in serosa-negative @entity356 : Japan Clinical Oncology Group 9206-1.

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity2592 :: ('MESH:D003561', 'Chemical') :: ['cytarabine'] @entity204 :: ('MESH:D003643', 'Disease') :: ['deaths'] @entity356 :: ('MESH:D013274', 'Disease') :: ['gastric cancer'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil']
@entity1487 :: (MESH:D005472,Chemical) :: ['Fluorouracil']
