Randomized trial on chest irradiation in extensive disease small cell lung cancer.
Completed
- Conditions
- PCISCLCED-SCLCthoracic radiotherapybrain metastasisprophylactic cranical irradiationextensive disease small cell lung cancerklein-cellig longkankerradiotherapie
- Registration Number
- NL-OMON21608
- Lead Sponsor
- VU University medical centerDept. of Radiation Oncology
- Brief Summary
se of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial , Slotman et al. The Lancet September 14, 2014 <br> http://dx.doi.org/10.1016/ S0140-6736(14)61085-0 <br> Comments in http://dx.doi.org/10.1016/ S0140-6736(14)61252-6
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 483
Inclusion Criteria
Cytologically or histologically proven small cell lung cancer
-Documented extensive disease (see appendix D) before the start of chemotherapy
Exclusion Criteria
None
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of this trial is to achieve an increase in 1 year survival of 10% (from 27% to 37%; HR=0.76). <br /><br>The Kaplan-Meier method will be used to estimate survival at different time points, and the logrank two sided test will be used to compare therapeutic arms according to the intent to treat policy.<br>
- Secondary Outcome Measures
Name Time Method The secondary endpoints are local control, pattern of failure and toxicity. Local control is defined as the absence of disease progression in the treated lobe/lung.