Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01372774
First received: June 11, 2011
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

RATIONALE: Stereotactic radiosurgery may be able to 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 radiosurgery is more effective than whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.

PURPOSE: This randomized phase III trial studies how well stereotactic radiosurgery works compared to whole-brain radiation therapy in treating patients with brain metastases that have been removed by surgery.


Condition Intervention Phase
Cognitive/Functional Effects
Metastatic Cancer
Neurotoxicity
Radiation Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: stereotactic radiosurgery
Radiation: whole-brain radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared With Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Neurocognitive progression at 6 months post-radiation in patients who received SRS compared to patients who received WBRT [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local control of the surgical bed [ Designated as safety issue: No ]
  • Time to CNS failure in these patients [ Designated as safety issue: No ]
  • Quality-of-life at 6 months of these patients [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: July 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients undergo whole brain radiotherapy (WBRT) once a day, 5 days a week, for approximately 3 weeks.
Radiation: whole-brain radiation therapy
Undergo radiotherapy (RT)
Experimental: Arm II
Patients undergo stereotactic radiosurgery (SRS) using a gamma knife or a linear accelerator procedure.
Radiation: stereotactic radiosurgery
Undergo RT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Four or fewer brain metastases (as defined on the pre-operative MRI brain scan) and status post resection of one of the lesions
  • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site

    • Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site
  • Any unresected lesions must measure ≤ 3.0 cm in maximal extent on the contrasted MRI brain scan obtained ≤ 35 days prior to pre-registration

    • The metastases size restriction does not apply to the resected brain metastasis; with resected brain metastases only surgical cavity size determines eligibility
  • Post-operative MRI confirmed zero, one, two or three unresected lesions

    • Each unresected lesion must measure ≤ 3.0 cm in maximal extent on the contrasted post-operative MRI brain scan
    • The pre-registration, post-operative, brain scan may be used for the randomization scan if obtained ≤ 28 days prior to randomization

      • Note: If there are no unresected brain metastases (i.e., all brain metastases have been resected), a post-operative CT brain scan may be used if obtained ≤ 28 days prior to randomization
  • Resection cavity must measure < 5.0 cm in maximal extent on the post-operative MRI (or CT) brain scan obtained ≤ 35 days prior to pre-registration

    • The pre-registration, post-operative brain scan may be used for the planning scan if obtained ≤ 28 days prior to randomization

      • Note: If there are no unresected brain metastases (i.e., all brain metastases have been resected), a post-operative CT brain scan may be used if obtained ≤ 28 days prior to randomization
    • It is permissible for the resection of a dominant brain metastasis to include a smaller "satellite" metastasis as long as the single resection cavity is less than the maximum size requirements
  • All standard tumor-staging procedures necessary to define baseline extracranial disease status completed ≤ 42 days prior to pre-registration
  • No primary germ cell tumor, small cell carcinoma, or lymphoma
  • No widespread definitive leptomeningeal metastasis
  • No brain metastasis that is located ≤ 5 mm of the optic chiasm or within the brainstem

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0, 1, or 2
  • Ability to be treated with either a gamma knife or a linear accelerator-based radiosurgery system
  • Willing and able to complete neurocognitive examination without assistance
  • Willing and able to complete quality-of-life (QOL) questionnaires by themselves or with assistance
  • Willing to provide mandatory blood and urine samples for correlative research purposes
  • None of the following:

    • Pregnant or nursing
    • Men or women of childbearing potential who are unwilling to employ adequate contraception through out the study and for men for up to 3 months after completing treatment
  • Able to complete a MRI with contrast of the head
  • No known allergy to gadolinium

PRIOR CONCURRENT THERAPY:

  • No prior cranial radiotherapy
  • No planned cytotoxic chemotherapy during the stereotactic radiosurgery (SRS) or whole-brain radiotherapy (WBRT)
  • Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372774

  Show 49 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Paul D. Brown, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Paul D. Brown, M. D. Anderson Cancer Center at University of Texas
ClinicalTrials.gov Identifier: NCT01372774     History of Changes
Other Study ID Numbers: CDR0000701474, NCCTG-N107C
Study First Received: June 11, 2011
Last Updated: February 15, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
neurotoxicity
radiation toxicity
cognitive/functional effects
tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neurotoxicity Syndromes
Radiation Injuries
Neoplastic Processes
Pathologic Processes
Nervous System Diseases
Poisoning
Substance-Related Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013