Whole Brain Radiotherapy + Stereotactic Radiosurgery for Brain Metastasis

Recruiting in Palo Alto (17 mi)

+76 other locations

Overseen byVinai Gondi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory. The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on thinking and memory. Stereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery may be effective in shrinking or stabilizing cancer that has spread to the brain and returned in other areas of the brain after receiving stereotactic radiosurgery.

Eligibility Criteria

This trial is for patients with certain cancers (like lung, breast, kidney cancer) that have spread to the brain and returned after initial treatment. Participants must have had their first or second relapse at least 8 weeks post-initial radiosurgery and within 21 days before joining the study. They should be able to undergo MRI scans, swallow pills, and not have severe co-morbidities or a history of specific conditions like multiple sclerosis.

Inclusion Criteria

The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

You have had at least 4 new brain metastases each year since getting initial treatment with SRS.

My brain lesions are less than 3.0 cm and total volume is under 30 mL.

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Exclusion Criteria

There are signs of changes or abnormal shape in the lateral ventricles in your brain scan.

I have a history of a disease like multiple sclerosis.

I cannot undergo MRI scans or use gadolinium contrast.

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Treatment Details

Interventions

Memantine (Other)
Stereotactic Radiosurgery (Radiation Therapy)
Whole-Brain Radiotherapy (Radiation Therapy)

Trial OverviewThe trial tests adding whole brain radiotherapy avoiding the hippocampus plus memantine against stereotactic radiosurgery alone in patients whose cancer has spread to the brain. The goal is to see if this combination better controls cancer growth while preserving memory by protecting a key part of the brain involved in this function.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (salvage SRS, memantine, HA-WBRT)Experimental Treatment5 Interventions

Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total of 10 fractions in the absence of disease progression or unacceptable toxicity. Within 1 week prior to or following HA-WBRT, patients undergo salvage SRS. Prior to HA-WBRT or no later than the 4th treatment, patients also receive memantine PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (salvage SRS)Active Control3 Interventions

Patients undergo salvage SRS.

Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Stereotactic Radiosurgery for: