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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborators:
American College of Surgeons
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT00377156
First received: September 13, 2006
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cognitive/Functional Effects
Lung Cancer
Metastatic Cancer
Prostate Cancer
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Neurocognitive progression [ Time Frame: 3 months post radiosurgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to CNS failure [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Quality of life, assessed by FACT-BR questionnaire, physician assessed neurological signs and symptoms, and treatment-related adverse events [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Neurocognitive status [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 238
Study Start Date: July 2006
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo stereotactic radiosurgery (SRS)
Radiation: stereotactic radiosurgery
No administration details available
Experimental: 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.
Radiation: radiation therapy
Patients undergo radiation therapy 5 days a week for 2.5 weeks
Radiation: stereotactic radiosurgery
No administration details available

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377156

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology-Deer Valley Center Recruiting
Phoenix, Arizona, United States, 85027
Contact: David Brachman, M.D.    602-240-3370      
Arizona Oncology Services Foundation Recruiting
Scottsdale, Arizona, United States, 85260
Contact: David G. Brachman, MD, FACRO    602-274-4484      
United States, California
Memorial Medical Center Recruiting
Modesto, California, United States, 95355
Contact: Clinical Trials Office - Memorial Medical Center    209-572-7116      
Kaiser Permanente - Division of Research - Oakland Recruiting
Oakland, California, United States, 94611
Contact: Louis Fehrenbacher, MD    707-651-2577      
St. Joseph Hospital Regional Cancer Center - Orange Recruiting
Orange, California, United States, 92868
Contact: Robert B. Ash    714-771-8999      
Rohnert Park Cancer Center Recruiting
Rohnert Park, California, United States, 94928
Contact: Louis Fehrenbacher, MD    707-651-2577      
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher, MD    707-651-2577      
Kaiser Permanente Medical Center - Santa Rosa Recruiting
Santa Rosa, California, United States, 95403
Contact: Louis Fehrenbacher, MD    707-651-2577      
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center    720-848-0650      
Veterans Affairs Medical Center - Denver Recruiting
Denver, Colorado, United States, 80220
Contact: Laurie Elizabeth W. Gaspar    303-399-8020      
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
United States, Georgia
Northside Hospital Cancer Center Recruiting
Atlanta, Georgia, United States, 30342-1611
Contact: Clinical Trials Office - Northside Hospital Cancer Center    404-303-3355      
Saint Joseph's Hospital of Atlanta Recruiting
Atlanta, Georgia, United States, 30342-1701
Contact: Clinical Trials Office - Saint Joseph's Hospital of Atlanta    404-851-7115      
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Richard J. LoCicero, MD    770-297-5700      
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Mark S. Quinn    912-819-6000      
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center    208-367-7954      
United States, Illinois
Northwest Community Hospital Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Stephen S. Nigh, MD    847-618-6560      
United States, Kansas
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
Owensboro Mercy Medical Center Recruiting
Owensboro, Kentucky, United States, 42303
Contact: Samuel Faught, M.D.    270-688-3600      
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Roland B. Hawkins    504-842-4360      
United States, Massachusetts
Lowell General Hospital Recruiting
Lowell, Massachusetts, United States, 01854
Contact: Jeffrey D. Goldstein    978-937-6000      
Saint Vincent Hospital at Worcester Medical Center Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Clinical Trials Office - Saint Vincent Hospital at Worcester M    508-363-7018      
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert A. Chapman, MD    313-916-1332      
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Robert Anthony Chapman    313-916-1850      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
United States, Minnesota
CCOP - Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
CentraCare Clinic - River Campus Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens    320-252-5131      
United States, Missouri
Cancer Institute of Cape Girardeau, LLC Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Tapan Roy, MD    573-334-2230      
Saint Luke's Cancer Institute at Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur, MD    913-948-5588      
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
United States, Nebraska
Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Gamini S. Soori, MD, FACP, FRCP, MBA    402-393-3110      
United States, New Hampshire
Seacoast Cancer Center at Wentworth - Douglass Hospital Recruiting
Dover, New Hampshire, United States, 03820
Contact: Arul Mahadevan    603-742-8787      
Elliot Regional Cancer Center at Elliot Hospital Recruiting
Manchester, New Hampshire, United States, 03103
Contact: Brian R. Knab    603-663-4201      
United States, New Jersey
Somerset Medical Center Recruiting
Somerville, New Jersey, United States, 08876
Contact: Clinical Trials Office - Somerset Medical Center    908-685-2481      
J. Phillip Citta Regional Cancer Center at Community Medical Center Recruiting
Toms River, New Jersey, United States, 08755
Contact: Clinical Trials Office - J. Phillip Citta Regional Cancer Cent    732-818-3882      
United States, North Carolina
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Stuart Burri, M.D.    704-355-2272      
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas    704-355-2884      
Cape Fear Valley Medical Center Cancer Center Recruiting
Fayetteville, North Carolina, United States, 28302-2000
Contact: Clinical Trial Office - Cape Fear Valley Medical Center Cance    910-609-4561      
Coastal Carolina Radiation Oncology Center Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Michael A. Papagikos    910-251-1839      
Forsyth Regional Cancer Center at Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Clinical Trials Office - Forsyth Regional Cancer Center at For    336-277-8887      
United States, North Dakota
Medcenter One Hospital Cancer Care Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: John T. Reynolds    701-323-5741      
Sanford Bismarck Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Preston Steen, M.D.    701-234-6161      
Sanford Bismarck Medical Center Recruiting
Bismark, North Dakota, United States, 58501
Contact: Preston Steen, M.D.    701-234-6161      
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Cancer Care Center, Incorporated Recruiting
Salem, Ohio, United States, 44460
Contact: William F. Demas, MD    330-375-3557      
Cancer Treatment Center Recruiting
Wooster, Ohio, United States, 44691
Contact: Clinical Trials Office - Cancer Treatment Center    330-375-4221      
United States, Oregon
Legacy Mount Hood Medical Center Recruiting
Gresham, Oregon, United States, 97030
Contact: Clinical Trials Office - Legacy Mount Hood Medical Center    503-413-2150      
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Recruiting
Portland, Oregon, United States, 97210
Contact: Clinical Trials Office - Legacy Good Samaritan Hospital & Com    503-413-1742      
Legacy Good Samaritan Hospital and Medical Center Recruiting
Portland, Oregon, United States, 97210
Contact: Andrew Kee, M.D.    503-413-4161      
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Frankford Hospital Cancer Center - Torresdale Campus Recruiting
Philadelphia, Pennsylvania, United States, 19114
Contact: Shari B. Rudoler    215-612-4880      
United States, South Carolina
Cancer Centers of the Carolinas - Faris Road Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere, MD, FACP    864-987-7000      
CCOP - Greenville Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey K. Giguere, MD, FACP    864-987-7000      
Greenville Cancer Center of the Carolinas (CCOP) Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey Giguere, M.D.    864-522-3065      
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Martin Colman, M.D.    409-772-6723      
United States, Washington
Legacy Salmon Creek Medical Center Recruiting
Vancouver, Washington, United States, 98686
Contact: Andrew Y. Kee    360-487-1000      
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
All Saints Cancer Center at Wheaton Franciscan Healthcare Recruiting
Racine, Wisconsin, United States, 53405
Contact: James H. Taylor, MD    262-687-5000      
Canada, Alberta
Tom Baker Cancer Centre - Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Gerald W. Lim    403-521-3723      
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Anthony C. Whitton    905-387-9495      
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Cynthia Menard    416-946-2811      
Canada, Quebec
CHUS-Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Abdenour Nabid, MD, FRCPC    819-346-1110ext.14602      
Sponsors and Collaborators
North Central Cancer Treatment Group
American College of Surgeons
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group
Investigators
Study Chair: Paul D. Brown, MD Mayo Clinic
Study Chair: Kurt A. Jaeckle, MD Mayo Clinic
Study Chair: Richard L. Deming, MD Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines
Study Chair: Bruce Pollock, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT00377156     History of Changes
Other Study ID Numbers: N0574, NCCTG-N0574, ACOSOG-N0574, CDR0000499633, NCI-2009-00653
Study First Received: September 13, 2006
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board
Canada: Research Ethics Board

Keywords provided by Alliance for Clinical Trials in Oncology:
cognitive/functional effects
tumors metastatic to brain
stage IV breast cancer
stage IV prostate cancer
stage IV non-small cell lung cancer
male breast cancer
recurrent breast cancer
recurrent prostate cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014