Clinical Trial Finder

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)

CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT in eligible patients with 11-20 BM on a triple dose gadolinium-enhanced MRI-scan. Neuropsychological assessment will be performed at baseline and at 3, 6, 9, 12 and 15 months after treatment. Follow-up assessments will be combined with 3-monthly MRI-scans. Patients will be randomized to either GKRS or WBRT. Groups will be balanced at baseline (prior to radiotherapy), taking into account several (stratification) factors that may influence cognitive functioning over time, such as: total tumor volume in the brain, systemic treatment, KPS, age, histology, and baseline HVLT-R total recall score.

Arms

Active Comparator: Stereotactic radiosurgery (SRS)

Gamma Knife radiosurgery

Active Comparator: Whole Brain Radiation Therapy (WBRT)

Whole Brain Radiation Therapy

Interventions

Radiation: - Gamma Knife radiosurgery

GKRS is performed with a Leksell Gamma Knife® Icon, Elekta Instruments, AB. Depending upon the volume, a dose of 18-25 Gy will be prescribed with 99-100% coverage of the target.

Radiation: - Whole Brain Radiation Therapy

Patients in the WBRT group will receive 4 Gy x 5 fractions (total of 20 Gy) in one week, which is a commonly utilized treatment schedule according to Dutch guidelines.