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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2008

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
American College of Surgeons
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00377156
  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
Brain and Central Nervous System Tumors
Breast Cancer
Cognitive/Functional Effects
Lung Cancer
Prostate Cancer
Procedure: radiation therapy
Procedure: stereotactic radiosurgery
Phase III

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Lung Cancer    Prostate Cancer    X-Rays   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to CNS failure [ Designated as safety issue: No ]
  • Quality of life, in terms of brain subscale and physical and emotional functioning, as measured by FACT-BR questionnaire, physician-assessed neurological signs and symptoms, and treatment-related adverse events at 3 months post treatment [ Designated as safety issue: Yes ]
  • Functional independence as measured by Barthel Activities of Daily Living Index and ECOG performance status [ Designated as safety issue: No ]
  • Duration of functional independence [ Designated as safety issue: No ]
  • Neurocognitive status as measured by objective assessment of changes in cognitive signs and symptoms and physician-assessed toxicities at 3 months post treatment [ Designated as safety issue: Yes ]

Estimated Enrollment:   528
Study Start Date:   July 2006
Estimated Primary Completion Date:   July 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Experimental
Patients undergo stereotactic radiosurgery (SRS)
Procedure: stereotactic radiosurgery
No administration details available
Arm II: Active Comparator
Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
Procedure: radiation therapy
Patients undergo radiation therapy 5 days a week for 2.5 weeks
Procedure: 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 528 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
  • No clinical or radiographic evidence of systemic progression (other than the study lesion[s]) within the past month
  • 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

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

Show 38 study locations  Show 38 Study Locations

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)
American College of Surgeons

Investigators
Study Chair:     Paul D. Brown, MD     Mayo Clinic    
Investigator:     Kurt A. Jaeckle, MD     Mayo Clinic    
Investigator:     Richard L. Deming, MD     Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines    
Investigator:     Elana Farace, PhD     Milton S. Hershey Medical Center    
Investigator:     Bruce Pollock, MD     Mayo Clinic    
Study Chair:     Anthony Asher, MD, FACS     Carolina Neurosurgery and Spine Associates    
Investigator:     Fred G. Barker, MD     Massachusetts General Hospital    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 
Featured trial article  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000499633, NCCTG-N0574, ACOSOG-N0574
First Received:   September 13, 2006
Last Updated:   July 10, 2008
ClinicalTrials.gov Identifier:   NCT00377156
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
cognitive/functional effects  
adult 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

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Breast Neoplasms
Urogenital Neoplasms
Central Nervous System Neoplasms
Genital Diseases, Male
Recurrence
Respiratory Tract Diseases
Breast Neoplasms, Male
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Nervous System Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on July 18, 2008




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