A pilot phaseII study of 3 dimensional stereotactic radiotherapy (3D-SRT) followed by maintenance therapy with oral UFT for stage IB non - small cell lung cancer
Phase 2
- Conditions
- non - small cell lung cancer, stageIB.
- Registration Number
- JPRN-C000000180
- Lead Sponsor
- Institute of Biomedical Research and Innovation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1)Apparent interstitial pneumonitis or fibrosis on chest X ray 2)Irradiation field larger than half of a ipsilateral lung 3)Double cancer within 5 years except for carcinoma in situ, intramucosal tumor, and basal cell carcinoma of the skin 4)History of previous chemotherapy 5)Pregnant woman, lactating woman, woman who has a possibility of pregnancy 6)Uncontrolled angina pectoris, myocardial infarction and congestive heart failure within three months 7)Uncontrolled diabetes mellitus 8)Active infectious disease 9)Fever more than 38 degrees Celsius 10)Steroid administration 11)Other complication unsuitable for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year survival
- Secondary Outcome Measures
Name Time Method Progression free survival, median survival time, local progression free survival time, local progression free survival at 3 years, pattern of progression or recurrence, adverse events, 5-year survival rate, local progression free survival at 5 years