A randomised phase II trial of combined therapy with CPT-11/CDDP versus CPT-11 alone in second-line treatment of advaneced or recurrent gastric cancer resistant to Docetaxel/Cisplatin/TS-1 (DCS) therapy
Phase 2
Recruiting
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-UMIN000003141
- Lead Sponsor
- Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
(1) With uncontrolled pleural effusion or ascites. (2) Active concomitant malignancy. (3) With infectious disease which needs treatment. (4) Uncontrolled medical conditions (e.g., congestive heart failure, ileus, interstitial pneumonia, pulmonary fibrosis, diabetes, interstitial pneumonia, pulmonary fibrosis, renal failure). (5) Watery stool (diarrhea). (6) With a history of mental disorder. (7) Pregnant or lactating women and women of child bearing potential not using contraception. (8) Drug hypersensitivity or severe drug allergy. (9) Inappropriate recruit to the study judged by an investigator in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method safety,response rate,overall survival,Time to Treatment Failure