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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Cisplatin

Criteria

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