Fractionated Stereotactic Radiation Therapy for Brain Cancer
Trial Summary
What is the purpose of this trial?
There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (MTD) in patients treated with FSRT. Prescription doses in the series described above ranged from 18 Gy to 42 Gy, delivered in 3 to 12 fractions. The results of this study will be used to plan future Phase II/III studies to determine the efficacy of different dose fractionation schedules of FSRT. We thus propose a phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot plan for chemotherapy or targeted agents during treatment. Hormonal and bone supportive therapies can be continued.
What data supports the effectiveness of the treatment Fractionated Stereotactic Radiation Therapy for brain cancer?
Research shows that Fractionated Stereotactic Radiotherapy (FSRT) is effective for treating small brain tumors and brain metastases, offering precise targeting and minimizing damage to surrounding healthy tissue. It has been particularly useful for tumors near critical structures, like the eyes, and has shown positive outcomes in maintaining function and controlling tumor growth.12345
Is Fractionated Stereotactic Radiation Therapy (FSRT) safe for treating brain conditions?
Research on FSRT for brain metastases shows it is generally safe, with studies focusing on its use for brain tumors from various cancers. FSRT is noted for having good control rates and manageable side effects, such as radiation necrosis (damage to brain tissue from radiation), which is a known risk but occurs infrequently.14678
How is Fractionated Stereotactic Radiation Therapy different from other treatments for brain cancer?
Fractionated Stereotactic Radiation Therapy (FSRT) is unique because it combines precise targeting of the tumor with the benefits of spreading out the radiation dose over several sessions, which can help protect nearby healthy brain tissue. This makes it particularly useful for treating tumors close to critical structures in the brain.12349
Research Team
Madhur Garg, MD
Principal Investigator
Montefiore
Eligibility Criteria
This trial is for adults with brain metastases larger than 3 cm but smaller than 6 cm, who haven't had surgery on the lesion. They can have had whole brain radiation before and may have other lesions treated separately. Participants need to be relatively active (Karnofsky ≥60 or ECOG ≤2), not pregnant, and expected to live more than 3 months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive Fractionated Stereotactic Radiation Therapy (FSRT) to determine the Maximum Tolerated Dose (MTD)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fractionated Stereotactic Radiation Therapy
Fractionated Stereotactic Radiation Therapy is already approved in United States, European Union, Canada, Japan for the following indications:
- Brain metastases
- Brain metastases
- Brain metastases
- Brain metastases
Find a Clinic Near You
Who Is Running the Clinical Trial?
Albert Einstein College of Medicine
Lead Sponsor