NCT00147147

Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by UFT in Serosa-positive Gastric Cancer (JCOG9206-2)

Randomized Trial of Adjuvant Chemotherapy With Cisplatin Followed by Oral Fluorouracil (UFT) in Serosa-positive Gastric Cancer (JCOG9206-2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (planned)
• Sponsor: Japan Clinical Oncology Group · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the survival benefit of adjuvant chemotherapy after curative resection with D2 or greater lymph node dissection in T3-4 gastric cancer patients.

Detailed description

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.

Conditions

• Gastric Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Gastrectomy with D2 or greater lymph node dissection
DRUG	Gastrectomy+ chemotherapy

Timeline

• Start date: 1993-01-01
• Completion: 2004-03-01
• First posted: 2005-09-07
• Last updated: 2016-09-22

Locations

1 site across 1 country: Japan