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. (see Contacts and Locations)
Verified July 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT01372774
First received: June 11, 2011
Last updated: July 22, 2013
Last verified: July 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
Intervention Model: Parallel Assignment
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 Alliance for Clinical Trials in Oncology:

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

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

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  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
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: NCT01372774

  Show 81 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: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT01372774     History of Changes
Other Study ID Numbers: N107C, NCCTG-N107C, CDR0000701474, NCI-2011-02676
Study First Received: June 11, 2011
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
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 July 22, 2014