RecruitingPhase 1NCT02390518

Stereotactic Radiosurgery Dose Escalation for Brain Metastases

Phase I Study of Stereotactic Radiosurgery Dose Escalation for Brain Metastases

Sponsor

University of Utah

Enrollment

50 participants

Start Date

May 7, 2015

Study Type

INTERVENTIONAL

Conditions

Brain Metastases

Summary

This is a Phase I dose escalation and expansion trial. The purpose of this study is to determine the maximum tolerated dose of radiation received during stereotactic radiosurgery in patients with brain metastases who have never received radiation to the brain before.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether higher doses of a very precise type of radiation treatment called stereotactic radiosurgery (SRS) — which targets tumors in the brain with pinpoint accuracy without open surgery — can safely and more effectively treat cancer that has spread to the brain from elsewhere in the body. **You may be eligible if...** - You are 18 or older - You have between 1 and 5 brain tumors confirmed by MRI or CT scan that have not yet been treated with radiation - Your tumors meet the specific size requirements for the trial group you are enrolling in - Your tumors are at least 3 cm apart from each other - You are in reasonably good health and able to perform most daily activities - Women of childbearing age must have a negative pregnancy test **You may NOT be eligible if...** - You have had radiation to the whole brain or a large portion of the brain before - Any of your brain tumors are larger than 40 mm in diameter - Your tumor is on the optic nerve or in the brain stem - You have cancer that has spread throughout the lining of the brain (leptomeningeal disease) - Your cancer type is small cell lung cancer, lymphoma, leukemia, multiple myeloma, or germ cell tumor - You are pregnant or breastfeeding 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

RADIATIONStereotactic Radiosurgery

Patients with 1 to 5 brain metastases will be treated. Patients will be assigned to one of four cohorts based on the size of their brain lesions. For each patient, a single lesion will be treated at experimental dose level, other metastases (if present) will receive standard SRS doses. Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Cohort 1a and 1a Expansion (starting at Dose Level 3) Diameter: ≤ 10 mm Volume: ≤ 0.5236 cm3 26 Gy 28 Gy 30 Gy n/a Cohort 1b Diameter: 11-20 mm Volume: 0.5237-4.1888 cm3 26 Gy 28 Gy 30 Gy n/a \*Cohort 2 Diameter: 21-30 mm Volume: 4.1889-14.1372 cm3 20 Gy 22 Gy 24 Gy n/a \*\*Cohort 3 Diameter: 31-40 mm Volume: 14.1373-33.5103 cm3 17 Gy 19 Gy 21 Gy 23 Gy Dose Escalation A non-standard 5+4 design will be used for the dose escalation. For each cohort, an initial group of 5 patients will be accrued at dose level 1 and receive experimental treatment to one of their lesions.