Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by 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.
Procedure: Gastrectomy with D2 or greater lymph node dissection
Drug: Gastrectomy+ chemotherapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-Positive Gastric Cancer (JCOG9206-2)|
- Overall survival
- Relapse-free survival
- the site of recurrence
|Study Start Date:||January 1993|
|Estimated Study Completion Date:||March 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147147
|Gastric Surgery Division, National Cancer Center Hospital|
|5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045|
|Study Chair:||Hiroshi Furukawa, MD, PhD||Sakai Municipal Hospital|