search
Back to results

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

Primary Purpose

Metastatic Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
radiation therapy
surgery
WBRT
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring tumors metastatic to brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of cerebral metastases meeting all of the following requirements: 1-3 de novo lesions Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s) Each lesion must be less than 3.0 cm by contrasted MRI of the brain Lesions must not be within 5 mm of optic chiasm or within the brainstem No primary germ cell tumor, small cell carcinoma, or lymphoma No leptomeningeal metastases Eligible for treatment with gamma knife or linear accelerator-based radiosurgery Performance status - ECOG 0-2 Performance status - Zubrod 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 body No known allergy to gadolinium Deemed to be at low risk for recurrence from any prior malignancies At least 7 days since prior chemotherapy Concurrent hormonal agents allowed Concurrent steroids allowed No prior cranial radiotherapy No prior resection of cerebral metastasis Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • St. Joseph's Hospital and Medical Center
  • Foundation for Cancer Research and Education
  • Mount Diablo Regional Cancer Center
  • Sutter Cancer Center
  • UCSF Comprehensive Cancer Center
  • John Muir Comprehensive Cancer Center at John Muir Medical Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Yale Comprehensive Cancer Center
  • Shands Cancer Center at the University of Florida Health Science Center
  • University of Illinois Medical Center
  • Genesis Regional Cancer Center at Genesis Medical Center
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Brigham and Women's Hospital
  • Barbara Ann Karmanos Cancer Institute
  • Josephine Ford Cancer Center at Henry Ford Health System
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • John F. Kennedy Medical Center
  • SUNY Upstate Medical University Hospital
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Carolina Neurosurgery and Spine Associates
  • American College of Surgeons Oncology Group
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Cleveland Clinic Taussig Cancer Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center - Shadyside Hospital
  • University of Pittsburgh Medical Center
  • UPMC St. Margaret
  • Methodist Cancer Center at Methodist University Hospital
  • American Fork Hospital
  • Cancer Center at the University of Virginia
  • Massey Cancer Center at Virginia Commonwealth University
  • University of Wisconsin Comprehensive Cancer Center
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

radiosurgery

radiosurgery + WBRT

Arm Description

Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.

Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Outcomes

Primary Outcome Measures

Overall survival (OS)

Secondary Outcome Measures

Time to CNS failure
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Change in the duration of functional independence using the Barthel ADL Index score

Full Information

First Posted
February 14, 2002
Last Updated
July 6, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00030628
Brief Title
Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Official Title
A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
Detailed Description
OBJECTIVES: Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy. Compare the time to CNS failure (brain) in patients treated with these regimens. Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens. Compare the post-treatment toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo radiosurgery. Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
tumors metastatic to brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiosurgery
Arm Type
Experimental
Arm Description
Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Arm Title
radiosurgery + WBRT
Arm Type
Experimental
Arm Description
Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Type
Radiation
Intervention Name(s)
WBRT
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Time to CNS failure
Time Frame
Up to 4 years
Title
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Time Frame
From baseline to up to 3 months
Title
Change in the duration of functional independence using the Barthel ADL Index score
Time Frame
From baseline to up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of cerebral metastases meeting all of the following requirements: 1-3 de novo lesions Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s) Each lesion must be less than 3.0 cm by contrasted MRI of the brain Lesions must not be within 5 mm of optic chiasm or within the brainstem No primary germ cell tumor, small cell carcinoma, or lymphoma No leptomeningeal metastases Eligible for treatment with gamma knife or linear accelerator-based radiosurgery Performance status - ECOG 0-2 Performance status - Zubrod 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 body No known allergy to gadolinium Deemed to be at low risk for recurrence from any prior malignancies At least 7 days since prior chemotherapy Concurrent hormonal agents allowed Concurrent steroids allowed No prior cranial radiotherapy No prior resection of cerebral metastasis Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Asher, MD, FACS
Organizational Affiliation
Carolina Neurosurgery and Spine Associates
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3295
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85001-2071
Country
United States
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mount Diablo Regional Cancer Center
City
Concord
State/Province
California
ZIP/Postal Code
94524-4110
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
John Muir Comprehensive Cancer Center at John Muir Medical Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8040
Country
United States
Facility Name
Shands Cancer Center at the University of Florida Health Science Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-100277
Country
United States
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Genesis Regional Cancer Center at Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
John F. Kennedy Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Carolina Neurosurgery and Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
American College of Surgeons Oncology Group
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
University of Pittsburgh Medical Center - Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC St. Margaret
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
Methodist Cancer Center at Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
American Fork Hospital
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Massey Cancer Center at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0631
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-7375
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs