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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Memantine
  • Hippocampal-avoidant (HA-WBRT) Radiotherapy
  • Stereotactic Radiosurgery (SRS)

Treatment groups

206 Participants
are divided into 2 treatment groups

Locations

86
Canada
Arthur J E Child Comprehensive Cancer CentreT2N 5G2, CalgaryAlberta, Canada
Cross Cancer InstituteT6G 1Z2, EdmontonAlberta, Canada
BCCA-Vancouver Cancer CentreV5Z 4E6, VancouverBritish Columbia, Canada
QEII Health Sciences Centre/Nova Scotia Health AuthorityB3H 2Y9, HalifaxNova Scotia, Canada

Sponsors and collaborators

Canadian Cancer Trials Group

Lead sponsor

Alliance for Clinical Trials in Oncology

Collaborator

NRG Oncology

Collaborator