This phase II trial tests magnetic response imaging (MRI) habitat-directed radiation in treating patients with high-grade soft tissue sarcoma. MRI habitats (images of tumor regions/subregions in different sequences) may identify the radioresistant cells within the tumor where precise and higher dose of radiation to the specific region of the tumor can be delivered. Intensity-modulated radiation therapy is a form of radiation therapy that uses high energy x-rays to deliver radiation to tumors and kill cancer cells and shrink tumors. Utilizing MRI habitat–directed radiation may improve the rate of favorable response (anti-tumor activity) at the time of surgery in patients with high-grade soft tissue sarcoma.
Additional locations may be listed on ClinicalTrials.gov for NCT05301283.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Arash Naghavi
Phone: 813-745-5236
PRIMARY OBJECTIVE:
I. To estimate the favorable pathologic response (FPR) of patients with resectable non-metastatic high-grade soft tissue sarcoma (STS) treated with magnetic resonance imaging (MRI) habitat-directed neoadjuvant radiation dose escalation.
SECONDARY OBJECTIVES:
I. Margin status: Estimate surgical margin, defined as tumor at ink by pathology.
II. Habitat pathologic response: Radiographic habitats delineated on pathology specimen will also be assessed to determine the difference in tumor response by various heterogenous portions of the tumor, as delineated by MRI-directed pre-radiation therapy (RT) clip placement.
III. Acute toxicity: Evaluate during weekly on-treatment visits up to 4 months (< 120 days) post-surgery.
IV. Disease control: Evaluate disease control with clinical/radiographic assessment.
V. Survival: Evaluate survival with clinical visit and/or phone call during trial period.
TERTIARY/EXPLORATORY OBJECTIVES:
I. Predict tumor response with early response imaging at weeks 2-3.
II. Prospectively collect tissue habitats for future genomicradiomic correlations and response to radiation.
III. Prospectively collect liquid biopsies for correlative studies regarding response to radiation.
IV. Correlation of diagnostic MRI and magnetic resonance guided linear accelerator (MR-linac) sequences.
OUTLINE: This is a dose escalation study.
Patients undergo MRI. Patients then undergo intensity-modulated radiation therapy (IMRT) 5 days per week for 5 weeks.
After completion of study treatment, patients are followed up for up to 4 months post surgery.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorArash Naghavi