Clinical trial · Interventional
Cognitive Outcome After SRS or WBRT in Patients With Multiple Brain Metastases (CAR-Study B)
A Prospective Randomized Study to Compare Cognitive Outcome After Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Patients With 11-20 Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gamma Knife radiosurgery | Radiation | — | UNRESOLVED |
| Whole Brain Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Stereotactic radiosurgery (SRS)
- description
- Gamma Knife radiosurgery
- interventionNames
- Radiation: Gamma Knife radiosurgery
- type
- ACTIVE_COMPARATOR
- label
- Whole Brain Radiation Therapy (WBRT)
- description
- Whole Brain Radiation Therapy
- interventionNames
- Radiation: Whole Brain Radiation Therapy
Primary outcomes (1)
- measure
- Cognitive decline at 3 months
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDSchimmel WCM, Verhaak E, Hanssens PEJ, Gehring K, Sitskoorn MM. A randomised trial to compare cognitive outcome after gamma knife radiosurgery versus whole brain radiation therapy in patients with multiple brain metastases: research protocol CAR-study B. BMC Cancer. 2018 Feb 21;18(1):218. doi: 10.1186/s12885-018-4106-2. PMID 29466961