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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. (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

September 13, 2006
August 19, 2013
July 2006
July 2014   (final data collection date for primary outcome measure)
Neurocognitive progression [ Time Frame: 3 months post radiosurgery ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00377156 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Cognitive/Functional Effects
  • Lung Cancer
  • Metastatic Cancer
  • Prostate Cancer
  • Radiation: radiation therapy
    Patients undergo radiation therapy 5 days a week for 2.5 weeks
  • Radiation: stereotactic radiosurgery
    No administration details available
  • Active Comparator: Arm I
    Patients undergo stereotactic radiosurgery (SRS)
    Intervention: Radiation: stereotactic radiosurgery
  • 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.
    Interventions:
    • Radiation: radiation therapy
    • Radiation: stereotactic radiosurgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
238
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States,   Canada
 
NCT00377156
N0574, NCCTG-N0574, ACOSOG-N0574, CDR0000499633, NCI-2009-00653
Yes
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
North Central Cancer Treatment Group
  • National Cancer Institute (NCI)
  • American College of Surgeons
  • Eastern Cooperative Oncology Group
  • Radiation Therapy Oncology Group
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
Alliance for Clinical Trials in Oncology
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP