Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients with Brain Metastases that have been Removed by Surgery

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Study phase:

    III What is this?

    During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Study IDs

  • Site IRB:

    • Scottsdale/Phoenix, Arizona: 11-001992
    • Rochester, Minnesota: 11-001992
  • NCT ID:

    NCT01372774
  • Sponsor Protocol Number:

    N107C

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Nadia Laack, M.D.

Closed for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Nadia Laack, M.D.

Closed for enrollment

Cancer Center Clinical Trials Referral Office

855-776-0015