Testing a new radiation therapy for brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I study aims to evaluate the safety and feasibility of Fractionated Stereotactic Radiation Therapy (FSRT) in patients with brain metastases. The study will determine the maximum tolerated dose (MTD) of FSRT, which has not been previously established in prospective trials. Patients with intact or surgically resected brain metastases will receive varying doses of FSRT, and the results will inform future Phase II/III studies on the efficacy of different dose fractionation schedules. The study addresses a significant gap in the current treatment guidelines for brain metastases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration
* Intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced MRI obtained within 30 days prior to registration OR Surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension
* Prior Whole Brain Radiation Therapy (WBRT) is allowed
* Age ≥ 18 years
* Women of childbearing potential and male participants must practice adequate contraception
* History/Physical examination within 30 days prior to registration
* Life expectancy \>3 months
* Patients are allowed to enroll if previously treated to other lesions with Stereotactic Radiosurgery (SRS)
* Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints

Exclusion Criteria:

* Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid (CSF) examination
* Plan for chemotherapy or targeted agents during treatment. Hormonal therapy, immunotherapy targeting PD-1/PD-L1 axis, and bone supportive therapy may be continued during treatment
* Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed
* Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy
* Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity
* Previous treatment of the target lesion with radiotherapy

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Madhur Garg, MD — Montefiore Medical Center
• Study coordinator: Nitin Ohri, MD
• Email: nitin.ohri@einsteinmed.edu
• Phone: 718-920-4140

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.