A randomized phase III trial of comparing two dose-fractionations stereotactic body radiotherapy (SBRT) for medically inoperable stage IA non-small cell lung cancer or small lung lesions clinically diagnosed as primary lung cancer (JCOG1408, J-SBRT trial)
Phase 3
Recruiting
- Conditions
- medically inoperable stage IA non-small cell lung cancer or small lung lesion (tumor diameter within 3cm) clinically diagnosed as primary lung cancer
- Registration Number
- JPRN-UMIN000021029
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
Not provided
Exclusion Criteria
1. Synchronous or metachronous (within 5 years) malignancies. 2. Active infection requiring systemic therapy. 3. Body temperature of 38 or more degrees Celsius. 4. Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast-feeding. 5. Severe mental disease. 6. Receiving continuous systemic steroid or immune-suppressive medication. 7. Idiopathic pulmonary fibrosis on CT. 8. Severe cough requiring narcortic drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method progression-free survival, local progression-free survival, patterns of failure, local control period, early and late adverse events, serious adverse events