Comparing the timing of radiotherapy and surgery for brain metastases
A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases
This study tests whether giving radiation therapy before or after surgery helps people with brain metastases feel better and have a better quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | AHS Cancer Control Alberta Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT04474925 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether administering stereotactic radiosurgery (SRS) before or after surgical resection leads to better outcomes for patients with brain metastases. It involves patients aged 18 and older with a confirmed primary malignancy who can undergo neurocognitive testing. The study will compare the effectiveness of pre-operative SRS versus post-operative SRS in improving patient outcomes and quality of life. Participants will be monitored for their response to treatment and any changes in brain function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a pathologically-proven primary malignancy and an ECOG performance status of 0-2.
Not a fit: Patients with prior whole-brain radiation therapy or those unable to undergo MRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients with brain metastases.
How similar studies have performed: Other studies have explored the timing of radiotherapy and surgery, but this specific comparison of pre- versus post-operative SRS is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Pathologically-proven primary malignancy * ECOG 0-2 * Ability to complete neurocognitive testing without assistance from family or friends. * Previous SRS to lesions other than the one being resected is allowed * Patients of childbearing / reproductive potential must have a negative urine or serum pregnancy test ≤7 days before enrollment * Participants capable of giving informed consent, or if appropriate participants having an acceptable individual capable of giving consent Exclusion Criteria: * Patients who have received prior WBRT, or SRS to the lesion being resected at time of study accrual * Patients unable to undergo MRI scan (e.g. pacemaker) * Leptomeningeal disease * Germ cell tumor, small cell lung cancer or hematological primary malignancy
Where this trial is running
Calgary, Alberta and 1 other locations
- Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- Cross Cancer Institute — Edmonton, Alberta, Canada (Withdrawn)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.