A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer

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

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborators: Ministry of Health, Labour and Welfare, Japan; Taiho Pharmaceutical Co., Ltd.; Yakult Honsha Co., LTD
• Treatments: Cisplatin; Fluorouracil; Irinotecan

Criteria

Inclusion Criteria:

1. unresectable or recurrent histologically proved gastric cancer

2. adequate oral intake

3. age 20 or older and 75 or younger

4. Performance Status (ECOG):0, 1, 2

5. measurable or unmeasurable lesions

6. preserved organ functions

7. no severe medical condition

8. no prior chemotherapy for gastric cancer

9. written informed consent

Exclusion Criteria:

1. patient with marked infection or inflammation

2. patient with severe peritoneal metastasis

3. patient with massive pleural effusion

4. patient with metastasis to CNS

5. patient with diarrhea 4 or more times per day

6. patient severe medical condition

7. patient with other concurrent malignancy affecting on survival or adverse events

8. pregnant or nursing patient or with intent to bear baby

9. patient evaluated to be inadequate by a attending doctor

10. patient requiring nutritional support