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Randomized trial on chest irradiation in extensive disease small cell lung cancer.

Completed
Conditions
PCI
SCLC
ED-SCLC
thoracic radiotherapy
brain metastasis
prophylactic cranical irradiation
extensive disease small cell lung cancer
klein-cellig longkanker
radiotherapie
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
NameTimeMethod
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
NameTimeMethod
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.   
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