Stereotactic Radiosurgery vs. HA-WBRT + Memantine for Brain Cancer
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using NMDA antagonists like amantadine, ketamine, or dextromethorphan.
What data supports the effectiveness of this treatment for brain cancer?
Is Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) safe for humans?
How is the treatment of Stereotactic Radiosurgery vs. HA-WBRT + Memantine for brain cancer different from other treatments?
This treatment is unique because it combines Stereotactic Radiosurgery (SRS), which precisely targets brain tumors, with Hippocampal-avoidant Whole Brain Radiation Therapy (HA-WBRT) that spares the hippocampus to reduce memory and cognitive side effects, and memantine, a drug that may help protect brain function.12345
Research Team
Vina Gondi
Principal Investigator
Northwestern Medicine Cancer Center, Warrenville IL
David Roberge
Principal Investigator
CHUM-Centre Hospitalier de l'Universite de Montreal
Michael Chan
Principal Investigator
Wake Forest School of Medicine, Winston-Salem, NC
Eligibility Criteria
This trial is for adults with 5 to 15 brain metastases from non-blood cancers, where the largest tumor is smaller than 2.5 cm. They must be able to undergo specific types of radiosurgery and HA-WBRT at certified centers, complete neurocognitive tests, and use effective contraception if needed. Excluded are pregnant/nursing individuals, those with allergies to gadolinium or memantine, prior cranial radiation therapy recipients, patients with certain brain conditions or liver disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either stereotactic radiosurgery (SRS) or hippocampal-avoidant whole brain radiotherapy (HA-WBRT) plus memantine
Follow-up
Participants are monitored for safety, effectiveness, and neurocognitive progression-free survival
Treatment Details
Interventions
- Hippocampal-avoidant (HA-WBRT) Radiotherapy
- Memantine
- Stereotactic Radiosurgery (SRS)
Hippocampal-avoidant (HA-WBRT) Radiotherapy is already approved in United States, Canada, European Union for the following indications:
- Brain metastases
- Research use only, not approved for general use
- Brain metastases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
Alliance for Clinical Trials in Oncology
Collaborator
NRG Oncology
Collaborator