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

  Show 65 Study Locations
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:
Lung Neoplasms
Prostatic Neoplasms
Breast Neoplasms
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014