Neoadjuvant Stereotactic Radiation Therapy for Resectable Brain Metastases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Rate of leptomeningeal failure
Study Overview
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 (resectable). Stereotactic radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor, and may cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the return of brain metastases less likely and help patients live longer compared to surgery followed by radiation therapy.
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 therapy (SRT).
SECONDARY OBJECTIVES:
I. Local control of brain metastases. II. Rate of salvage treatment including surgery, SRS, SRT, or whole brain radiation therapy (WBRT).
III. Dose and volume of radiation to adjacent normal brain parenchyma. IV. Rate of symptomatic radiation necrosis/steroid dependency. V. Rate of distant brain failure. VI. To compare overall survival (OS) between the 2 groups. VII. To determine the number of patients who die due to neurologic causes. VIII. To assess quality of life as assessed using Functional Assessment of Cancer Therapy?Brain (FACT?BR).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Arm A (SRS/SRT, surgery)
Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy.
Intervention: Quality-of-Life Assessment (Other)
Arm A (SRS/SRT, surgery)
Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy.
Intervention: Questionnaire Administration (Other)
Arm A (SRS/SRT, surgery)
Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy.
Intervention: Stereotactic Radiosurgery (Radiation)
Arm A (SRS/SRT, surgery)
Patients undergo 1, 5, or 10 fraction of SRS/SRT radiation. Surgery is performed within 72 hours of radiation therapy.
Intervention: Therapeutic Conventional Surgery (Procedure)
Arm B (surgery, SRS/SRT)
Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT.
Intervention: Quality-of-Life Assessment (Other)
Arm B (surgery, SRS/SRT)
Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT.
Intervention: Questionnaire Administration (Other)
Arm B (surgery, SRS/SRT)
Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT.
Intervention: Stereotactic Radiosurgery (Radiation)
Arm B (surgery, SRS/SRT)
Within 2-5 weeks after standard of care surgery, patients undergo 1, 5, or 10 fraction of SRS/SRT.
Intervention: Therapeutic Conventional Surgery (Procedure)
Outcomes
Primary Outcomes
Rate of leptomeningeal failure
Time Frame: Up to 2 years
A two-sided Z test with pooled variance will be used at significance level =0.1 to test if there is a difference in leptomeningeal failure rate between the two treatment groups.
Secondary Outcomes
- Rate of symptomatic radiation necrosis/steroid dependency(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Time to progression(Up to 2 years)
- Dose (Gy) and volume (cc) of radiation to adjacent normal brain parenchyma(Up to 2 years)
- Rate of salvage treatment including surgery, SRS, SRT, or WBRT(Up to 2 years)
- Rate of distant brain failure(Up to 2 years)
- Genetic expression profiles in pre vs post radiation tumor tissue(Up to 2 years)
- Death due to neurological causes(Up to 2 years)
- Quality of life assessment: FACTBR(Up to 2 years)