Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.

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

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma

• Unresectable and recurrent gastric cancer

• Age 20 to 74

• Performance status 0, 1, or 2 (ECOG)

• Life expectancy 3 months

• No prior chemotherapy or radiotherapy for gastric cancer

• Able to take oral medication

• Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study

• Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL

• Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL

• Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min

Exclusion Criteria:

• Pregnant or nursing

• Bleeding from gastrointestinal tract or no diarrhea

• Hypersensitivity to TS-1 or CDDP

• Psychiatric disorder that would preclude study compliance or giving informed consent

• Severe acute or chronic medical or psychiatric condition or laboratory abnormality

• Serious illness or medical condition

• Brain metastasis

• Ascites requiring drainage