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

Not Applicable

• Conditions: S-1 failure for Patients with Advanced and Recurrent Gastric Cancer

• Registration Number: JPRN-UMIN000001028
• Lead Sponsor: The Tokyo cooperative oncology group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-01
• Study Completion: 2012-08-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival

Secondary Outcome Measures

Name	Time	Method
OS TTF Anti-tumor Effect(Response rate) Adverse Event