RecruitingPhase 1NCT03726359

Phase I Study of Fractionated Stereotactic Radiation Therapy

Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases

Sponsor

Albert Einstein College of Medicine

Enrollment

43 participants

Start Date

Dec 25, 2017

Study Type

INTERVENTIONAL

Conditions

Brain Metastases

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a type of focused radiation treatment called fractionated stereotactic radiation therapy (FSRT) for people who have cancer that has spread to the brain in tumors measuring between 3–6 cm. **You may be eligible if...** - You have been diagnosed with a non-blood cancer (not small cell lung cancer) that has spread to the brain - You have a brain tumor between 3 and 6 cm that has not been surgically removed, OR you have had a brain tumor removed and radiation to the surgical site is recommended - You are 18 years or older - You are in reasonable health with a life expectancy greater than 3 months - You are willing to use contraception if applicable **You may NOT be eligible if...** - Your cancer has spread along the lining of the brain (called leptomeningeal disease) - You are currently on chemotherapy or targeted cancer drugs during treatment (hormonal therapy and certain immunotherapy drugs are allowed) - You cannot have an MRI scan (e.g., due to metal implants that are not MRI-compatible) - Your brain tumor came from small cell lung cancer or germ cell cancer - You have uncontrolled serious heart or other health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONFractionated Stereotactic Radiation Therapy (FSRT)

Initial starting dose will be 7 Gy x5= 35 Gy delivered to the planning target volume (PTV). Radiotherapy will be delivered every other day so that the Stereotactic Body Radiation Therapy (SBRT) schedule is completed within 1.5-2 weeks.