Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Study summary

RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases. PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedradiation therapy and stereotactic radiosurgery

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 16, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?64 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Alliance for Clinical Trials in Oncology
Interventions being studied: Radiation: radiation therapy; Radiation: stereotactic radiosurgery

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Treatment approach

Radiation therapy→Surgery→

Study topics

Brain metastases→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

DISEASE CHARACTERISTICS:
Diagnosis of cerebral metastases meeting the following criteria:
One to three presumed brain metastases
Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate)
Histologic confirmation may have been from the primary tumor site, from another metastatic site (e.g., osseous metastasis, adrenal metastasis), or from the metastatic brain lesion(s)
Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed within the past 21 days
Lesions must not be within 5 mm of the optic chiasm or within the brainstem
Eligibility for treatment with gamma knife or linear accelerator-based radiosurgery confirmed by a radiation oncologist
No primary germ cell tumor, small cell carcinoma, or lymphoma
No leptomeningeal metastases
Hormone receptor status not specified PATIENT CHARACTERISTICS:
Male or female
Menopausal status not specified
ECOG performance status 0-2
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
Male patients must continue to use contraception for 3 months after the completion of radiotherapy
No pacemaker or other MRI-incompatible metal in the body
No known allergy to gadolinium PRIOR CONCURRENT THERAPY:
More than 7 days since prior and no concurrent chemotherapy
No prior cranial radiotherapy
No prior resection of cerebral metastases
Concurrent hormonal agents, steroids, and/or anticonvulsants allowed

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Arizona Oncology-Deer Valley CenterPhoenix, Arizona
Arizona Oncology Services FoundationScottsdale, Arizona
Memorial Medical CenterModesto, California
Kaiser Permanente - Division of Research - OaklandOakland, California
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California
Rohnert Park Cancer CenterRohnert Park, California
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado
Veterans Affairs Medical Center - DenverDenver, Colorado
Mayo Clinic - JacksonvilleJacksonville, Florida
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2022. Always confirm current availability with the study team.

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