WJOG7512L:A randomized phase III study of maintenance therapy with TS-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus TS-1 for advanced or relapsed squamous cell carcinoma of the lung
Phase 3
- Conditions
- Advanced or relapsed squamous cell carcinoma of the lung
- Registration Number
- JPRN-UMIN000010396
- 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
Induction therapy 1) SVC syndrome 2) Clinically significant drug allergy 3) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment 4) Have received radiation therapy or surgery to lesions of lung 5) Patient received palliative radiotherapy except to the primary lesion in last 2 weeks. 6) With severe infection, bleeding, cardiac diseases. 7) With continues diarrhea 8) Ileus or sub-ileus 9) With interstitial pneumonia, sever COPD 10) Symptomatic brain metastasis 11) Presence of other active malignancy 12) Un-controlled DM 13) Uncontrolled psychiatric disease. 14) pregnancy or lactating patients 15) Positive serum HBs antigen 16) Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival from the date of randomization for maintenance therapy
- Secondary Outcome Measures
Name Time Method Overall survival, QOL and adverse events from the date of randomization for maintenance therapy, Progression free survival and overall survival from the date of enrollment