RecruitingBrain Metastases

Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

Eligible age

18+ yrs

Accepts

All genders

Locations

26 states

Healthy volunteers

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About this study

Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain. Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms. Health Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.

Sponsor: Canadian Cancer Trials Group

You may qualify if…

✓ Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain metastases).
✓ Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.
✓ The largest brain metastasis must measure \<2.5 cm in maximal diameter.
✓ Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.
✓ Patient must be \> 18 years of age.
✓ Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French either alone or with assistance.
✓ ECOG performance status 0, 1, or 2.
✓ Creatinine clearance must be ≥ 30 ml/min within 28 days prior to registration.

You may not qualify if…

✕ Pregnant or nursing women.
✕ Men or women of childbearing potential who are unwilling to employ adequate contraception.
✕ Inability to complete a brain MRI.
✕ Known allergy to gadolinium.
✕ Prior cranial radiation therapy.
✕ Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.
✕ Primary germ cell tumour, small cell carcinoma, or lymphoma.
✕ Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy, leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF) positive for tumour cells.