This phase II trial tests the effectiveness of using a magnetic resonance imaging (MRI) device combined with a linear accelerator (MR LINAC) for stereotactic body radiation therapy (SBRT) in treating tumors in the spine. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. A linear accelerator is a machine that creates high energy radiation that is used to treat cancer. A MR LINAC provides more advanced images of the spine during radiation treatment. Using a MR LINAC during SBRT may lead to improved responses to treatment and a better quality of life.
Additional locations may be listed on ClinicalTrials.gov for NCT05709782.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Debra Nana Yeboa
Phone: 713-792-5933
PRIMARY OBJECTIVE:
I. To determine the 6-month local progression free survival (LPFS) rate of the target site of treatment from start of treatment to 6 month follow up after spine stereotactic radiosurgery (SSRS)/SBRT for each patient cohort. (FOR THERAPEUTIC COHORT)
II. To determine mean intra- or inter-fractional motion across subjects and descriptively review theoretical adaptive plans. (FOR IMAGING ONLY COHORT)
SECONDARY OBJECTIVE:
I. To determine the volumetric measurement of 6-month change in epidural tumor volume (when applicable) & 1-year LPFS rate of the target site. (FOR THERAPEUTIC COHORT)
EXPLORATORY OBJECTIVES:
I. To evaluate cord motion using MR imaging. (FOR THERAPEUTIC COHORT)
II. To evaluate dosimetric changes in radiation therapy (RT) planning with regarding tumor dose, tumor dose escalation, and cord dosing. (FOR THERAPEUTIC COHORT)
III. To calculate the change in thecal sac patency (by volumetric measurement) and in Bilsky cord compression. (FOR THERAPEUTIC COHORT)
IV. To evaluate frequency of tumor related pain, pain flare symptoms and symptom interference as well as quality of life before and after treatment. (FOR THERAPEUTIC COHORT)
V. To evaluate the rate of radiation myelitis or late effects. (FOR THERAPEUTIC COHORT)
VI. To collect tissue and blood samples for future studies seeking to correlate changes in peripheral blood biomarkers (genes, micro ribonucleic acid [RNA], proteins, lymphocyte count, etc) and the study endpoints. (FOR THERAPEUTIC COHORT)
OUTLINE: Patients are assigned to 1 of 2 cohorts.
Cohort I: Patients undergo spine SBRT using MR LINAC and may also undergo MRI throughout the trial.
Cohort II: Patients undergo imaging using MR LINAC on study.
After completion of treatment, patients in Cohort I are followed up in months 3, 6, 9, 12, 18, and 24.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDebra Nana Yeboa
