CompletedPhase 3NCT00377156

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

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.

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

StatusCompleted
PhasePhase 3
U.S. locations64
SponsorAlliance for Clinical Trials in Oncology
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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.

04
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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