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

Sponsor:	North Central Cancer Treatment Group
Collaborators:	National Cancer Institute (NCI) American College of Surgeons Eastern Cooperative Oncology Group Radiation Therapy Oncology Group
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
Breast Cancer Cognitive/Functional Effects Lung Cancer Metastatic Cancer Prostate Cancer	Radiation: radiation therapy Radiation: stereotactic radiosurgery	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Genetics Home Reference related topics: breast cancer

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

U.S. FDA Resources

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:	238
Study Start Date:	July 2006
Estimated Primary Completion Date:	July 2011 (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

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

Show 45 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

American College of Surgeons

Eastern Cooperative Oncology Group

Radiation Therapy Oncology Group

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
Study Chair:	Larry Kleinberg, MD	Sidney Kimmel Comprehensive Cancer Center

More Information

Additional 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

No publications provided

Responsible Party:	Jan C. Buckner, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier:	NCT00377156 History of Changes
Other Study ID Numbers:	CDR0000499633, NCCTG-N0574, ACOSOG-N0574
Study First Received:	September 13, 2006
Last Updated:	July 27, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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 February 13, 2012