Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery
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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 |
- 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 ]
- 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 |
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
Show 49 Study Locations| 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