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 个研究点目标入组 534 人开始时间: 2006年9月22日最近更新: 2022年4月4日

适应症

试验速览

•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

•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

发起方

Medical Research Council (MRC) (UK)