NIPH Clinical Trials Search

UMIN ID: UMIN000001028

Registered date:01/04/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedS-1 failure for Patients with Advanced and Recurrent Gastric Cancer
Date of first enrollment2008/03/01
Target sample size130
Countries of recruitmentJapan
Study typeInterventional
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


Primary OutcomeProgression-free Survival
Secondary OutcomeOS TTF Anti-tumor Effect(Response rate) Adverse Event

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Address Japan
Affiliation The Tokyo cooperative oncology group Clinical Study Promotion Agency
scientific contact
Name Wasaburou Koizumi
Address 2-1-1 Asamizodai Sagamihara-shi Kanagawa Japan Japan
Affiliation Kitazato Univercity East Hospital Digestive Internal Medicine