Randomized phase II trial of UFT plus Cisplatin versus Pemetrexed plus Cisplatin combined with Concurrent Thoracic Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer. North Japan Lung Cancer Study Group Trial 1001 (NJLCG1001)
Phase 2
Recruiting
- Conditions
- non-small-cell lung cancer
- Registration Number
- JPRN-UMIN000003948
- Lead Sponsor
- Miyagi Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
Not provided
Exclusion Criteria
1) Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan 2) Malignant pleural or pericardial effusion or ascites 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 or radiotherapy 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