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

Phase 3

Completed

• Conditions: Gastric Neoplasm

• Registration Number: NCT00147147
• Lead Sponsor: Japan Clinical Oncology Group

Brief 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.

Study Timeline

• Study Start: 1993-01
• Study Completion: 2004-03
• Study First Submitted: 2005-09-05
• Study First Submitted QC: 2005-09-05
• Study First Posted: 2005-09-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Curative operation with D2 or greater lymph node dissection
2. Histologically proven gastric adenocarcinoma
3. Macroscopically serosa-positive (T3-4)
4. No metastases to level 3 - 4 lymph nodes station (N0-2)
5. 75 years or younger
6. Negative peritoneal lavage cytology
7. Adequate organ function WBC >=4000/mm3,Hb >=11.0g/dl,Plt >=100.000/mm3,AST/ALT, T.Bil, BUN, Creatinine <=2.5 x Normal Upper Limit,Creatinine clearance <=70 ml/min
8. Written informed consent

Exclusion Criteria

1. Prior chemotherapy or radiotherapy
2. Synchronous or metachronous malignancy in other organs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Relapse-free survival
the site of recurrence

Trial Locations

Locations (1)

Gastric Surgery Division, National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan