A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor
Phase 2
- Conditions
- on Small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000001658
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1) clinically significant drug allergy 2) Under treatment with flucytosine, phenytoin, Warfarin Potassium, other trial drugs. 3) The infection which needs the medical treatment by antibiotics, and other serious complications 4) The case which has diarrhea continuously 5) The case which has clear interstitial pneumonia or a clear fibroid lung with a chest simple X ray 6) The case which has malignant tumors other than the lung cancer 7) The case which has the past of a malignant tumor 8) Not suitable for participating in the study for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival of 2 years, to searches for the chemotherapy effect prediction factor.
- Secondary Outcome Measures
Name Time Method Overall survival (OS), Rate of adverse events, Relative dose intensity, to searches for a prognosis prediction factor.