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

Phase 3

Completed

Conditions: Cognitive/Functional Effects
Metastatic Cancer
Breast Cancer
Lung Cancer
Prostate Cancer

Interventions: Radiation: stereotactic radiosurgery
Radiation: radiation therapy

Registration Number: NCT00377156

Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed Description: OBJECTIVES:

Primary

* Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy.

Secondary

* Compare time to CNS (brain) failure in patients treated with these regimens.

* Compare quality of life, duration of functional independence, and long-term neurocognitive status of patients treated with these regimens.

* Compare post-treatment toxicity in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for \> 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo stereotactic radiosurgery (SRS).

* Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life, functional independence, and neurocognitive status are assessed at baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48, and 60 months.

PROJECTED ACCRUAL: A total of 238 patients will be accrued for this protocol.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 213

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	stereotactic radiosurgery	Patients undergo stereotactic radiosurgery (SRS)
Arm II	radiation therapy	Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
Arm II	stereotactic radiosurgery	Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.

Primary Outcome Measures

Name	Time	Method
Neurocognitive Progression as Measured by the Number of Participants With Cognitive Deterioration by 3 Months	3 months post radiosurgery	The primary endpoint was cognitive deterioration (progression), defined as a decline of greater than 1 SD from baseline on at least 1 of 7 cognitive tests (all tests are standardized based on published norms and transformed so that higher values represent improved cognition) at the 3-month post-SRS evaluation. The number of participants who experienced cognitive deterioration by 3 months is reported for each arm below. For primary analysis of the 3-month cognitive deterioration endpoint, the Fisher exact 2-group binomial test was used to compare the proportion of evaluable patients with 3-month cognitive deterioration between the 2 groups.

Secondary Outcome Measures

Name	Time	Method
Long-Term Neurocognitive Status (Long-Term Cognitive Status), as Measured by Percentage of Long-term Survivors With Cognitive Deterioration at 12 Months	From baseline to 12 months	Long-Term Neurocognitive Status \> To ascertain in patients with one to three brain metastases whether there is better long-term neurocognitive status in patients who receive SRS alone (Arm A) compared to patients who receive SRS combined with WBRT (Arm B). Long-term survival status is defined as evaluable patients who survived for at least 12 months and had at least one cognitive assessment on or after 365 days.
Overall Survival	Up to 5 years	Overall survival, defined as the time from randomization until death due to any cause, was compared between the groups using stratified log-rank tests.
Number of Participants With Local and Distant Tumor Control up to 3 Months	Up to 3 months	Number of Participants with Local and Distant Tumor Control up to 3 months is defined as....
Overall Quality of Life, as Measured by Mean Change From Baseline [3 Month]	From Baseline to 3-Month Evaluation	Quality of Life was assessed using the Functional Assessment of Cancer Therapy-Brain, for which the range is from 0 to 200 and higher scores indicate better QOL. The Quality of Life (QOL) scores were transformed to a 0- to 100-point scale (with 100 being most favorable), in which a 10-point change was considered clinically significant. Intergroup changes in QOL scores were compared using a 2-sample t test.

Trial Locations

Locations (64): Arizona Oncology Services Foundation
🇺🇸
Scottsdale, Arizona, United States
Kaiser Permanente - Division of Research - Oakland
🇺🇸
Oakland, California, United States
Memorial Medical Center
🇺🇸
Modesto, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
🇺🇸
Orange, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
🇺🇸
Santa Clara, California, United States
Rohnert Park Cancer Center
🇺🇸
Rohnert Park, California, United States
Kaiser Permanente Medical Center - Santa Rosa
🇺🇸
Santa Rosa, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸
Aurora, Colorado, United States
Mayo Clinic - Jacksonville
🇺🇸
Jacksonville, Florida, United States
Northside Hospital Cancer Center
🇺🇸
Atlanta, Georgia, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸
Orlando, Florida, United States
Saint Joseph's Hospital of Atlanta
🇺🇸
Atlanta, Georgia, United States
Northeast Georgia Medical Center
🇺🇸
Gainesville, Georgia, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
🇺🇸
Savannah, Georgia, United States
Northwest Community Hospital
🇺🇸
Arlington Heights, Illinois, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
🇺🇸
Boise, Idaho, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸
Wichita, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Owensboro Mercy Medical Center
🇺🇸
Owensboro, Kentucky, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Saint Vincent Hospital at Worcester Medical Center
🇺🇸
Worcester, Massachusetts, United States
Lowell General Hospital
🇺🇸
Lowell, Massachusetts, United States
West Michigan Cancer Center
🇺🇸
Kalamazoo, Michigan, United States
CCOP - Duluth
🇺🇸
Duluth, Minnesota, United States
Cancer Institute of Cape Girardeau, LLC
🇺🇸
Cape Girardeau, Missouri, United States
Mayo Clinic Cancer Center
🇺🇸
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸
Saint Cloud, Minnesota, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Billings Clinic - Downtown
🇺🇸
Billings, Montana, United States
Immanuel Medical Center
🇺🇸
Omaha, Nebraska, United States
Seacoast Cancer Center at Wentworth - Douglass Hospital
🇺🇸
Dover, New Hampshire, United States
Elliot Regional Cancer Center at Elliot Hospital
🇺🇸
Manchester, New Hampshire, United States
Somerset Medical Center
🇺🇸
Somerville, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
🇺🇸
Toms River, New Jersey, United States
Carolinas Medical Center/Levine Cancer Institute
🇺🇸
Charlotte, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Coastal Carolina Radiation Oncology Center
🇺🇸
Wilmington, North Carolina, United States
Cape Fear Valley Medical Center Cancer Center
🇺🇸
Fayetteville, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Medcenter One Hospital Cancer Care Center
🇺🇸
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
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Bismarck, North Dakota, United States
Cancer Treatment Center
🇺🇸
Wooster, Ohio, United States
Legacy Mount Hood Medical Center
🇺🇸
Gresham, Oregon, United States
Cancer Care Center, Incorporated
🇺🇸
Salem, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸
Akron, Ohio, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸
Danville, Pennsylvania, United States
Frankford Hospital Cancer Center - Torresdale Campus
🇺🇸
Philadelphia, Pennsylvania, United States
CCOP - Greenville
🇺🇸
Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
🇺🇸
Greenville, South Carolina, United States
Greenville Cancer Center of the Carolinas (CCOP)
🇺🇸
Greenville, South Carolina, United States
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
🇺🇸
Racine, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸
Green Bay, Wisconsin, United States
Legacy Salmon Creek Medical Center
🇺🇸
Vancouver, Washington, United States
Tom Baker Cancer Centre - Calgary
🇨🇦
Calgary, Alberta, Canada
Margaret and Charles Juravinski Cancer Centre
🇨🇦
Hamilton, Ontario, Canada
Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada
CHUS-Hopital Fleurimont
🇨🇦
Sherbrooke, Quebec, Canada
Arizona Oncology-Deer Valley Center
🇺🇸
Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Veterans Affairs Medical Center - Denver
🇺🇸
Denver, Colorado, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
🇺🇸
Portland, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
🇺🇸
Portland, Oregon, United States