A Randomized, phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small-cell lung cancer HOT1401/NJCLG1401
Phase 2
- Conditions
- chemotherapy-naive extensive disease small-cell lung cancer
- Registration Number
- JPRN-UMIN000013882
- Lead Sponsor
- orth Japan Lung Cancer Study Group and Hokkaido Lung Cancer Clinical Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1) Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan 2) History of heart disorder. 3) Severe co-morbidities (ex. uncontrolled heart or lung or hepatic or renal disease or diabetes) 4) Regular use of corticosteroid (less than 2 weeks interval after cessation) 5) Pregnancy or lactation, or those who decline contraception 6) Contraindication with chemotherapy 7) Active concomitant malignancy. Except carcinoma in situ or those who did not relapse 5-years or more 8) Those judged to be not suitable by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method