Whole Brain Radiotherapy (WBRT) versus Stereotactic Radiosurgery (SRS) for 4 up to 10 brain metastases: a phase III randomized multicenter trial
Phase 3
Completed
- Conditions
- brain metastases10027476
- Registration Number
- NL-OMON47148
- Lead Sponsor
- MAASTRO Clinic
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
* Age*18 years
* Minimal 4 up to a maximum of 10 brain metastases (BM) on diagnostic MRI scan
* Maximum PTV of the largest BM of 65 cm3
* Karnofsky performance status * 70
* Any solid primary tumour. Small cell lung cancer, germinoma, and lymphoma are excluded
* Ability to provide written informed consent
Exclusion Criteria
* Contra-indication for MRI
* Prior treatment for brain metastases (i.e. surgery, SRS or WBRT)
* Concurrent use of systemic therapy
* More than 10 BM on plannings-MRI
* A brainstem metastasis with a PTV of more than 20 cm3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference in quality of life (EQ-5D EUROQOL score) at 3 months<br /><br>post-radiotherapy with respect to baseline</p><br>
- Secondary Outcome Measures
Name Time Method <p>Difference in quality of life (EQ5D EUROQOL score) at 6, 9, and 12 months<br /><br>post-radiotherapy with respect to baseline. At 3, 6, 9, and 12 months after<br /><br>radiotherapy survival, Karnovsky*70, WHO performance status, steroid use (mg),<br /><br>toxicity according CTCAE V4.0 including hair loss, fatigue, neurocognition<br /><br>question, and brain salvage during follow-up, type of salvage, time to salvage<br /><br>after randomization, and Barthel index.<br /><br><br /><br>Facultative secondary endpoints are neurocognition with the Hopkins Verbal<br /><br>Learning Test, quality of life EORTC QLQ-C30, quality of life EORTC BN20 brain<br /><br>module, and fatigue scale EORTC QLQ-FA13. </p><br>