Brain radiation showdown: which saves memory better?
NCT ID NCT03775330
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at two types of radiation for people with 5 to 30 brain tumors that have spread from other cancers. One group gets focused radiation (SRS) alone, the other gets whole-brain radiation plus SRS. The main goal is to see which approach better protects memory and thinking skills. About 126 adults with non-blood cancers are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The participant population will be patients who have MRI-documented 5 to 30, inclusive, brain metastases at time of enrollment and who are suitable for receiving stereotactic radiosurgery (SRS) and whole brain radiation (WBRT), with or without hippocampal-avoidance.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologic or cytologic diagnosis of non-hematopoietic malignancy (excluding germ cell malignancies and small cell carcinoma). * Patients with ≥ 5 but ≤ 30 de novo brain metastases seen on a diagnostic-quality contrast-enhanced MRI obtained within 30 days prior to enrollment (or randomization if previously randomized). Patients who are found to have 31-50 metastatic lesions at the time of treatment planning may still participate in the study. Disease progression such that \> 50 brain metastases are detected after initial MRI prior to enrollment but before SRS will be treated off-protocol as per discretion of the treating physician. * Patients with ≥ 5 but ≤ 30 new brain metastases who have undergone prior SRS for 4 or less brain metastases with stable intracranial disease as per diagnostic MRI for at least 6 months post last course of SRS. Patients who are found to have 31-50 new metastatic lesions at the time of treatment planning may still participate in the study. Disease progression such that \> 50 new brain metastases are detected after initial MRI prior to enrollment but before SRS will be treated off-protocol as per discretion of the treating physician. * Age ≥ 18. * Karnofsky Performance Status (KPS) ≥ 70. * Baseline HVLT-R above ≥ 6 * Patients must be able to tolerate WBRT, and all brain lesions must be eligible for treatment with SRS as determined by the radiation oncologist. * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. * Patient is able to read, speak, and understand (i.e. sufficiently fluent) English in order to allow completion and meaningful analyses of the neurocognitive tests and quality of life questionnaires. * Patients must be accessible for treatment and follow up. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * Patients who are on immunotherapy must have immunotherapy held at least 1 week before and after completion of radiotherapy. Other targeted agents/therapy must be held at least 1 day before and after SRS. Systemic chemotherapy must be held one week prior to treatment and re-started one week after treatment is complete. * Protocol treatment is to begin within 4 weeks of patient enrollment (or randomization if previously randomized). Exclusion Criteria: * Patients with brain metastases resulting from germ cell malignancies, small cell carcinoma, or hematologic malignancies. * Prior SRS for 5 or more brain metastases or any SRS for brain metastases within the last 6 months. * Any prior WBRT or radiotherapy for brain metastases such that the study interventions cannot be delivered. * Prior surgical resection of metastatic cancer from the brain. * Patients with evidence of leptomeningeal disease. * Patients who have a pacemaker or other contraindications, such that gadolinium-enhanced MRI cannot be performed or treatment cannot be delivered safely. * Patients who have received chemotherapy or immunotherapy within 1 week prior to administration of protocol radiotherapy or who are expected / planned to receive chemotherapy within one week of completing protocol radiotherapy. * Patients with \< 5 or \> 30 de novo or new brain metastases at time of enrollment, or \> 50 brain metastases at time of treatment planning. * Patients who are pregnant (women of child-bearing age must have negative pregnancy urine test within 7 days of enrollment or randomization).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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