Randomized Phase III Trial of Irinotecan plus Cisplatin vs. bi-weekly Irinotecan after S-1 failure for Patients with Advanced and Recurrent Gastric Cancer

UMIN ID: UMIN000001028

Registered date:01/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
• Date of first enrollment: 2008/03/01
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

CPT-11+CDDP arm: CPT-11(60mg/m2) day1 CDDP(30mg/m2) day1 Every 2 weeks
CPT-11 arm: CPT-11(150mg/m2) day1 Every 2 weeks

Outcome(s)

• Primary Outcome: Progression-free Survival
• Secondary Outcome: OS TTF Anti-tumor Effect(Response rate) Adverse Event

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. a patient who received transfusion, blood products, or hematopoietic growth factors such as G-CSF within 7 days prior to the registration 2. S-1+CPT-11 combination therapy as the first line chemotherapy 3. Advanced gastric cancer that refuses operation 4. History of severe drug allergic reaction 5.serious pleural effusion or ascites 6.serious Infectious disease 7. Watery diarrhea 8. Intestinal obstruction or Intestines paralysis 9. Intestinal fresh hemorrhage 10. With serious lung disease 11.administering atazanavir sulfate 12. Symptomatic brain metastasis 13. Active secondary cancer 14. cardiac disease 15. psychiatric disease or nervous disease 16. preganat or nursing patients and patients who may be pregnant 17. Decision as ineligible by principal investigator

Related Information

• Primary Sponsor: The Tokyo cooperative oncology group
• Source(s) of Monetary Support: The Tokyo cooperative oncology group