43 Participants Needed

Fractionated Stereotactic Radiation Therapy for Brain Cancer

AA
Overseen ByAlyssa Asaro, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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

MG

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

Age ≥ 18 years
Women of childbearing potential and male participants must practice adequate contraception
History/Physical examination within 30 days prior to registration
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Exclusion Criteria

You have brain tumors caused by certain types of cancer.
You cannot have metal implants that are not safe for MRI scans. If you have MRI-safe implants, you can still participate.
You have a serious health condition that is not being managed well, like heart problems or seizures.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive Fractionated Stereotactic Radiation Therapy (FSRT) to determine the Maximum Tolerated Dose (MTD)

3-12 fractions

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

  • Fractionated Stereotactic Radiation Therapy
Trial OverviewThe study tests Fractionated Stereotactic Radiation Therapy (FSRT) to find the highest dose patients can tolerate without severe side effects. This Phase I trial will set the stage for future studies by establishing safe dosage levels of FSRT in treating brain metastases.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Fractionated Stereotactic Radiation TherapyExperimental Treatment1 Intervention
This study is unique in that it employs a continuous reassessment methodology (CRM) to determine the Maximum Tolerated Dose. Information for the proper dose level for each subsequent patient enrolled will be determined based on DLTs from previous patients enrolled in the trial.

Fractionated Stereotactic Radiation Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Fractionated Stereotactic Radiation Therapy for:
  • Brain metastases
🇪🇺
Approved in European Union as Fractionated Stereotactic Radiotherapy for:
  • Brain metastases
🇨🇦
Approved in Canada as Fractionated Stereotactic Radiation Therapy for:
  • Brain metastases
🇯🇵
Approved in Japan as Fractionated Stereotactic Radiation Therapy for:
  • Brain metastases

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials
302
Recruited
11,690,000+

Findings from Research

Fractionated stereotactic radiotherapy (FSRT) demonstrated high local control rates and low morbidity in treating small intracranial malignancies, with a median survival of 21.2 months for patients without extracranial tumors.
The study involved 80 patients with 121 tumors, showing that while FSRT is effective, patients with certain risk factors may require smaller radiation doses to minimize potential late radiation injuries.
Fractionated stereotactic radiotherapy of small intracranial malignancies.Tokuuye, K., Akine, Y., Sumi, M., et al.[2022]
Fractionated stereotactic radiotherapy (FSRT) is a safe and effective treatment for cavernous sinus meningiomas, achieving a local progression-free survival rate of 93% over a median follow-up of 50 months among 30 patients.
The treatment led to improvement in preexisting neurological symptoms for 50% of patients, with only a small number experiencing late radiation toxicity, indicating good tolerance and minimal cognitive decline post-treatment.
Fractionated stereotactic radiotherapy in the treatment of exclusive cavernous sinus meningioma: functional outcome, local control, and tolerance.Brell, M., Villà, S., Teixidor, P., et al.[2018]
In a study of 13 patients with parasellar meningiomas treated with fractionated stereotactic radiotherapy (FSRT), 12.5% of eyes showed improved visual acuity, while 75% remained stable, indicating a generally positive outcome.
FSRT was found to be safe, as no adverse visual outcomes were reported, and over half of the eyes (57%) experienced improvements in visual field, suggesting its efficacy in treating tumors near critical structures.
Fractionated stereotactic radiotherapy for parasellar meningiomas: a preliminary report of visual outcomes.Behbehani, RS., McElveen, T., Sergott, RC., et al.[2018]

References

Fractionated stereotactic radiotherapy of small intracranial malignancies. [2022]
Fractionated stereotactic radiotherapy in the treatment of exclusive cavernous sinus meningioma: functional outcome, local control, and tolerance. [2018]
Fractionated stereotactic radiotherapy for parasellar meningiomas: a preliminary report of visual outcomes. [2018]
Fractionated stereotactic radiation therapy for intact brain metastases. [2022]
Plan Quality Assessment of Fractionated Stereotactic Radiotherapy Treatment Plans in Patients With Brain Metastases. [2022]
Treatment Outcomes After Higher-dose Fractionated Stereotactic Radiotherapy (FSRT) Alone for 1-4 Brain Metastases. [2023]
Clinical outcomes of biological effective dose-based fractionated stereotactic radiation therapy for metastatic brain tumors from non-small cell lung cancer. [2022]
Outcomes of Hypofractionated Stereotactic Radiotherapy for Small and Moderate-Sized Brain Metastases: A Single-Institution Analysis. [2022]
Early versus Delayed Fractionated Stereotactic Radiotherapy for Nonfunctioning Pituitary Adenoma. [2023]