Details

Details

Title N107C A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) compared with whole brain radiotherapy (WBRT) for resected metastatic brain disease

IRB NCCTG107C

CC 12-123

Hospital Main Campus

Phase Phase 3

Disease Brain

Description

Description

Primary
  1. To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  2. To determine in patients with one to four brain metastases whether there is less neurocognitive progression at 6 months post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
Secondary
  1. To determine in patients with resected brain metastases whether there is improved QOL in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  2. To determine in patients with one to four brain metastases whether there is equal longer time to central nervous system (CNS) failure (brain) in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  3. To determine in patients with one to four brain metastases whether there is longer duration of functional independence in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  4. To determine in patients with one to four brain metastases whether there is better long-term neurocognitive status in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
  5. To tabulate and descriptively compare the post-treatment adverse events associated with the interventions.
  6. To evaluate local tumor bed recurrence at 6 months with post-surgical SRS to the surgical bed in comparison to WBRT.
  7. To evaluate time to local recurrence with post-surgical SRS to the surgical bed in comparison to WBRT.
  8. To evaluate if there is any difference in CNS failure patterns (local, distant, leptomeningeal) in patients who receive SRS to the surgical bed compared to patients who receive WBRT.
Inclusion Criteria

Inclusion Criteria

  1. Four or fewer brain metastases and status post resection of one of the lesions.
  2. Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site.
  3. 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 unresected lesions will be treated with SRS as outlined in the treatment section of the protocol.
  4. Resection cavity must measure lt; 5.0 cm in maximal extent on the post-operative MRI (or CT) brain scan obtained =35 days prior to pre-registration.
  5. All standard tumor-staging procedures necessary to define baseline extracranial disease status completed ≤ 42 days prior to pre-registration.
  6. Ability to be treated with either a gamma knife or a linear accelerator-based radiosurgery system.
  7. Age ≥ 18 years.
  8. Willing and able to complete neurocognitive examination without assistance.
  9. Willing and able to complete QOL by themselves or with assistance
  10. ECOG Performance Status (PS) 0, 1, or 2.
  11. SRS facility is Radiological Physics Center (RPC) approved
  12. The site study team member performing neurocognitive testing of patients must have credentialing confirming completion of the neurocognitive testing training.
  13. Provide informed written consent.
  14. Willing to provide mandatory blood and urine samples for correlative research purposes.
Exclusion Criteria

Exclusion Criteria

  1. Any of the following: pregnant woman, nursing women, 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.
  2. Prior cranial RT (radiation therapy).
  3. Inability to complete a MRI with contrast of the head.
  4. Known allergy to gadolinium.
  5. Planned cytotoxic chemotherapy during the SRS or WBRT.
  6. Primary germ cell tumor, small cell carcinoma, or lymphoma.
  7. Widespread definitive leptomeningeal metastasis.
  8. A brain metastasis that is located ≤ 5 mm of the optic chiasm or within the brainstem.