A Randomized Phase II Clinical Trial of Tailored CPT-11 + S-1 vs S-1 in Patients with Advanced or Recurrent Gastric Carcinoma as the First Line Chemotherapy

UMIN ID: C000000099

Registered date:31/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced or recurrent gastric cancer
• Date of first enrollment: 2003/08/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Arm A (tailored CPT-11 + S-1): CPT-11 (75mg/m2) is given biweekly for 4 weeks (one cycle). If the manifested toxicity defined by NCI-CTC criteria, is 0 or 1 (grade 0 for diarrhea) during the first cycle, increase 25mg/m2 of CPT-11 to 100mg/m2, if grade 2 toxicity (grade 1 for diarrhea) is observed, maintain the same dose, and if toxicities of grade 3 (grade 2 for diarrhea) and more is shown, decrease 25mg/m2 of CPT-11 to 50mg/m2 for the second cycle. We repeat the dose adjustment every cycle in the same manner. S-1 is given one of the following doses twice daily, after breakfast and dinner; body surface area <1.25m2, 40mg; 1.25-1.50m2, 50mg; >=1.5m2, 60mg. S-1 is administered at the respective dose for 14 days, followed by a 14days rest period (one cycle).
Arm B (S-1): S-1 is given in the same dose of Arm A, and administered for 28 days, followed by a 14days rest period (one cycle).

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Response duration, Time to progression (TTP), Overall survival, Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) History of using S-1 2) Medical history of allergy or hypersensitivity reactions to any drug 3) Serious effusion of cancerous fluids such as pleural effusion and/or ascites 4) Serious infectious disease 5) Diarrhea 6) Ileus or colon dysfunction 7) Lung fibrosis 8) Intake of flucitosine 9) Synchronous or metachronous or other types of malignancies 10) Uncontrollable diabetes mellitus 11) Serious heart disease 12) Serious psychological disease 13) Pregnancy 14) Patients judged inappropriate for this study by the physicians

Related Information

• Primary Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Japanese Foundation for Multidisciplinary Treatment of Cancer