Cognitive Outcome After SRS or WBRT in Patients With Multiple Brain Metastases (CAR-Study B) (NCT02953717) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Outcome After SRS or WBRT in Patients With Multiple Brain Metastases (CAR-Study B)
Netherlands81 participantsStarted 2016-02
Plain-language summary
Whole Brain Radiation Therapy (WBRT) has long been the mainstay of treatment for patients with multiple brain metastases (BM). Meanwhile, Gamma Knife radiosurgery (GKRS) has been increasingly employed in the management of multiple BM to spare healthy tissue. Hence, GKRS is expected to cause fewer cognitive side effects than WBRT. Treatment of multiple BM without cognitive side effects is becoming more important, as more patients live longer due to better systemic treatment options. There are no published randomized trials yet directly comparing GKRS to WBRT in patients with multiple BM, including objective neuropsychological testing.
CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT in eligible patients with 11-20 BM.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven malignant cancer
* 11-20 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan
* Maximum total tumor volume ≤ 30 cm3
* Lesion ≥ 3 mm from the optic apparatus
* Age ≥ 18 years
* Karnofsky Performance Status (KPS) ≥ 70
* Anticipated survival \> 3 months
Exclusion Criteria:
* No prior histologic confirmation of malignancy
* Primary brain tumor
* A second active primary tumor
* Small cell lung cancer (SCLC)
* Lymphoma
* Leukemia
* Meningeal disease
* Progressive, symptomatic systemic disease without further treatment options
* Prior brain radiation
* Prior surgical resection of BM
* Cardiovascular accident (CVA) \< 2 years ago
* Additional history of a significant neurological or psychiatric disorder
* Contra indications to MRI or gadolinium contrast
* Underlying medical condition precluding adequate follow-up
* Participation in a concurrent study in which neuropsychological testing and/or health-related QOL assessments are involved
* Lack of basic proficiency in Dutch
* IQ below 85
* Severe aphasia
* Paralysis grade 0-3 according to MRC scale (Medical Research Council)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.