Gastric Neoplasm Clinical Trial
Official title:
Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-positive Gastric Cancer (JCOG9206-2)
To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.
Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection
in serosa-positive gastric cancer patients, a multicenter phase III clinical trial was
conducted by 13 participating centers in Japan. Methods: From January 1993 to March 1998,
268 patients were randomized to either adjuvant chemotherapy (135 pts) or surgery alone (133
pts). The chemotherapy comprised intraperitoneal cisplatin 70 mg/m2 before closing the
abdomen, and after surgery intravenous cisplatin 70 mg/m2 (day 14) and 5-fluorouracil (5-FU)
700 mg/m2 daily (day 14-16), and oral FU (UFT) 267 mg/m2 daily from 4 weeks after surgery
for the next 12 months. The primary endpoint was overall survival. Relapse-free survival and
the site of recurrence were secondary endpoints.
Comparison: gastrectomy with D2 or greater lymph node dissection versus gastrectomy with
adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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