What side effects are associated with this type of intervention?

The most common treatments for brain metastasis include Single Fraction Stereotactic Radiosurgery (SFSR) and Fractionated Stereotactic Radiosurgery (FSRS). SFSR, which delivers a high dose of radiation in one session, can cause acute side effects such as headaches, nausea, and fatigue, and has a higher risk of radiation necrosis. FSRS, which administers smaller doses over multiple sessions, tends to have fewer acute side effects but may still cause fatigue, skin reactions, and hair loss. Both treatments carry a risk of long-term side effects, including cognitive decline and radiation necrosis, but FSRS is generally associated with a lower risk of severe complications compared to SFSR.

What prior FDA approvals exist?

The FDA has approved various stereotactic radiosurgery (SRS) and fractionated stereotactic radiosurgery (SRT) techniques for the treatment of brain metastasis. SRS delivers a high dose of radiation in a single session, while SRT administers smaller doses over multiple sessions. These methods are designed to target tumors precisely, minimizing damage to surrounding healthy tissue. Specific drugs are not typically involved in these radiation therapies, but they are often used in conjunction with other treatments such as chemotherapy or immunotherapy to manage brain metastases.

What other types of research exist?

Promising novel alternatives to Single Fraction Stereotactic Radiosurgery (SRS) and Fractionated Stereotactic Radiosurgery (FSRS) for brain metastasis patients include: 1) Brachytherapy, which involves implanting radioactive sources directly into or near the tumor, allowing for higher radiation doses with limited exposure to surrounding brain tissue. 2) Laser Interstitial Thermal Therapy (LITT), which uses laser energy to ablate tumor tissue and can be guided by MRI for precision. 3) Systemic therapies such as immunotherapy and targeted therapies, which have shown potential in controlling both systemic and intracranial disease, particularly in cancers like melanoma and certain subtypes of non-small cell lung cancer (NSCLC).

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Radiation Therapy

Stereotactic Radiosurgery for Brain Metastasis

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Resection cavity must measure < 5.0 cm in maximal extent and the resection must be complete on the post-operative MRI obtained =< 30 days prior to pre-registration

Must be fluent in English, Spanish, or French

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two radiation treatments for patients with brain cancer that has spread and been surgically removed. One treatment uses a single session of radiation, while the other uses several sessions. The goal is to see which method is more effective and has fewer side effects.

Who is the study for?

This trial is for patients with up to three brain metastases from cancer that has spread, but not from germ cell tumors, small cell carcinoma, or lymphoma. Participants must have had one tumor surgically removed within the last 30 days and can't have had whole brain radiation before. They should be able to complete questionnaires in English, Spanish, or French and undergo MRI scans.

What is being tested?

The study compares single-dose stereotactic radiosurgery (a high dose of targeted radiation) with fractionated stereotactic radiosurgery (smaller doses over time) for treating resected brain metastasis. It aims to determine which method is more effective and less harmful to healthy tissue.

What are the potential side effects?

Potential side effects may include headaches, nausea, fatigue, hair loss at the treatment site, swelling in the brain around the treated area (edema), hearing changes if near auditory structures; rarely seizures or neurological deficits depending on location.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery area is smaller than 5.0 cm and fully removed, confirmed by a recent MRI.

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I am fluent in English, Spanish, or French.

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My cancer has spread to the protective covering of the brain.

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My cancer has not spread to the lining of my brain and spinal cord.

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My brain tumor originated from another part of my body.

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I can care for myself but cannot do normal activities or work.

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I have up to 3 brain tumors that haven't been surgically removed.

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My untreated cancer spots are smaller than 4.0 cm on my latest brain MRI.

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My brain tumor was larger than 2 cm before surgery.

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My brain cancer is not near the optic nerve or brainstem.

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I have never had whole brain radiation therapy.

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My cancer is not a germ cell tumor, small cell carcinoma, or lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Surgical bed recurrence-free survival (SB-RFS)

Secondary study objectives

Barthel Activities of Daily Living (ADL) Index

Barthel Activities of Daily Living (ADL) Index for long-term survivors

Brain

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (FSRS)Experimental Treatment3 Interventions

Patients undergo FSRS over 3 or 5 daily sessions.

Group II: Arm I (SSRS)Active Control3 Interventions

Patients undergo SSRS over 1 session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quality-of-Life Assessment

2017

Completed Phase 3

~4950

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for brain metastasis include Single Fraction Stereotactic Radiosurgery (SFSRS) and Fractionated Stereotactic Radiosurgery (FSRS). SFSRS delivers a high dose of radiation in one session, targeting the tumor precisely while minimizing damage to surrounding healthy tissue, making it suitable for small, well-defined tumors and reducing the number of hospital visits. FSRS administers smaller doses over multiple sessions, which can lower the risk of radiation-induced toxicity and is often used for larger or more complex tumors. These treatment mechanisms are important for brain metastasis patients as they help customize therapy to maximize effectiveness and minimize side effects.

Re-irradiation of brain metastases and metastatic spinal cord compression: clinical practice suggestions.