Phase I Study of Fractionated Stereotactic Radiation Therapy (NCT03726359)
Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases
🩺 Plain-English Summary (8th-Grade Level)
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. The investigator team thus proposes a Phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.
Who can join: Review the eligibility criteria below.
Location: Montefiore Medical Center — The Bronx, New York
Age range: 18 Years
🧪 Interventions in This Study
- Fractionated Stereotactic Radiation Therapy (FSRT) (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Montefiore Medical Center — The Bronx, New York
📞 Contact the Study Coordinator
Phone: (718) 920-4140
Email: nitin.ohri@einsteinmed.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Brain Metastases
- Preop fSRS for Resectable Brain Metastases — Tampa, Florida
- Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases — Washington D.C., District of Columbia
- Study Assessing QBS72S For Treating Brain Metastases — Palo Alto, California
- A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy — Houston, Texas
- Neurocognitive Decline in Patients With Brain Metastases — Dallas, Texas
- MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases — Durham, North Carolina
Explore by condition: All Brain Metastases clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.