Status:
WITHDRAWN
Stereotactic Radiation Therapy Before Surgery for the Treatment of Resectable Brain Metastases
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Malignant Neoplasm, Brain
Brain Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial studies how well stereotactic radiation therapy before surgery works in treating patients with cancer that has spread to the brain (brain metastases) and can be removed by surgery (resectab...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the rate of leptomeningeal failure after neoadjuvant radiation therapy (NaRT) versus (vs) postoperative stereotactic radiosurgery (SRS)/stereotactic radiation thera...
Eligibility Criteria
Inclusion
- Prior histologic diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
- 1?4 cerebral metastases per magnetic resonance imaging (MRI) with at least 1 being dominant and eligible for resection
- No prior radiation treatment for the index brain metastases
- Systemic disease staged within previous 8 weeks and not rapidly progressing, with concern of life expectancy \> 3 months
- The patients will have been evaluated by the multidisciplinary team, and surgery must be deemed necessary as a result of indications including but not limited to mass effect or symptomatic lesion. Surgery must be deemed non?emergent or non?urgent clinically by the neurosurgeon
- Karnofsky performance status (KPS) \>= 70
- No active infections requiring systemic antibiotics
- If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment
- Ability to understand and willingness to sign a written informed consent
Exclusion
- Patient deemed medically unfit to undergo surgical resection of brain metastasis
- Prior whole brain radiotherapy
- Patient with contraindication for imaging with MRI
- Surgery is considered emergent or urgent by the neurosurgeon due to symptoms or concerning mass effect noted on imaging
- Patients who are participating in a concurrent treatment protocol
- At the time of planning, unable to meet dose tolerance of the optic nerve/chiasm
- Tumor located in the brainstem
- Imaging or cytologic evidence of leptomeningeal disease
- Concurrent uncontrolled illness including, but not limited to, any of the following: Symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04069910
Start Date
August 26 2019
End Date
November 30 2020
Last Update
January 31 2022
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095