Phase I Study of Fractionated Stereotactic Radiation Therapy

Launched by ALBERT EINSTEIN COLLEGE OF MEDICINE · Oct 30, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Fractionated Stereotactic Radiation Therapy (FSRT) for patients with brain metastases, which are cancerous growths that have spread to the brain from other parts of the body. The goal of this Phase I study is to determine the highest dose of FSRT that patients can safely receive. Currently, there isn't enough research on how to use FSRT effectively for this condition, and the findings from this trial will help shape future studies that will test how well different doses work.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of a type of cancer (except small cell lung cancer) that has spread to the brain. They must have measurable brain metastases and recent MRI scans to show their condition. Importantly, participants should not have had surgery on the targeted tumor or previous radiation treatment for it. While on the trial, patients will receive FSRT and will be closely monitored for safety and side effects. This study is currently recruiting participants, and it's a chance to contribute to new knowledge that could improve treatment for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• 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