Trial record 1 of 1 for:    n0574
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Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

This study is ongoing, but not recruiting participants.
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: June 10, 2015
Last verified: June 2015
  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
Primary Completion Date: October 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
Phoenix, Arizona, United States, 85027
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States, 85260
United States, California
Memorial Medical Center
Modesto, California, United States, 95355
Kaiser Permanente - Division of Research - Oakland
Oakland, California, United States, 94611
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States, 95051
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States, 95403
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
United States, Georgia
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Northwest Community Hospital
Arlington Heights, Illinois, United States, 60005
United States, Kansas
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
Owensboro Mercy Medical Center
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
Saint Vincent Hospital at Worcester Medical Center
Worcester, Massachusetts, United States, 01608
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States, 63703
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
United States, Nebraska
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, New Hampshire
Seacoast Cancer Center at Wentworth - Douglass Hospital
Dover, New Hampshire, United States, 03820
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Somerset Medical Center
Somerville, New Jersey, United States, 08876
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Cape Fear Valley Medical Center Cancer Center
Fayetteville, North Carolina, United States, 28302-2000
Coastal Carolina Radiation Oncology Center
Wilmington, North Carolina, United States, 28401
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismark, North Dakota, United States, 58501
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Greenville Cancer Center of the Carolinas (CCOP)
Greenville, South Carolina, United States, 29615
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
United States, Washington
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States, 98686
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
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: June 10, 2015
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:
Neoplasm Metastasis
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on July 01, 2015