ISRCTN13826061
Completed
Phase 3
A phase III multi-centre randomised controlled trial to assess whether optimal supportive care alone (including dexamethasone) is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy in the treatment of patients with inoperable brain metastases from non-small cell lung cancer
Medical Research Council (MRC) (UK)0 sites534 target enrollmentSeptember 22, 2006
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- on-small cell lung cancer with inoperable brain metastases
- Sponsor
- Medical Research Council (MRC) (UK)
- Enrollment
- 534
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23211715 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27604504 results
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically or cytologically proven primary NSCLC
- •2\. Computed tomography (CT)/magnetic resonance imaging (MRI) confirming brain metastases
- •3\. Inoperable brain metastases as assessed by a lung cancer Multi\-Disciplinary Team (MDT) or patients for whom surgery is deemed inappropriate
- •4\. Clinician and patient uncertain of the role of whole brain radiotherapy (WBRT)
- •5\. Patient able and willing to respond to questions in a weekly telephone assessment
- •6\. Patient able and willing to give informed consent
- •7\. Aged over 18 years
- •8\. Baseline patient assessment form completed
Exclusion Criteria
- •Current exclusion criteria as of 14/01/2014:
- •1\. Clinician and/or patient certain that WBRT will be of benefit
- •2\. Clinician and/or patient certain that WBRT will not be of benefit
- •3\. Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons
- •4\. Chemotherapy (last cycle) within 3 weeks prior to randomisation
- •5\. Previous radiotherapy to the brain
- •6\. Surgery for brain metastases within one month prior to randomisation
- •Previous exclusion criteria:
- •1\. Clinician and/or patient certain that WBRT will be of benefit
- •2\. Clinician and/or patient certain that WBRT will not be of benefit
Outcomes
Primary Outcomes
Not specified
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