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

Phase 3

Completed

• Conditions: on-small cell lung cancer with inoperable brain metastases; Cancer; Lung cancer

• Registration Number: ISRCTN13826061
• Lead Sponsor: Medical Research Council (MRC) (UK)

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-22
• Study Completion: 2015-05-31
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 534

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
3. Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons
4. Estimated glomerular filtration rate (EGFR) inhibitors within one week prior to randomisation
5. Chemotherapy (last cycle) within one month prior to randomisation
6. Previous radiotherapy to the brain
7. Surgery for brain metastases within one month prior to randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality-adjusted life-years. Follow-up is weekly until 12 weeks, then 4 weekly, until death.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Overall survival<br> 2. Karnofsky Performance Status<br> 3. Patient symptoms<br> Follow-up is weekly until 12 weeks, then 4 weekly, until death.<br>