This phase I/II trial studies the side effects and best dose of proton-spatially fractionated radiotherapy (P-SFRT) and to see how well it works with standard radiation therapy in treating patients with newly diagnosed abdomino-pelvic soft tissue sarcoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard spatially fractionated radiotherapy (SFRT) refers to how the radiation is delivered to the tumor. SFRT means that different parts of the tumor are receiving different doses of radiation (fractionation) through beams that allow areas of higher and lower (peaks and valleys) of doses of the radiation. This spatial fractionation allows an overall high-dose radiation to be given in the peaks and those areas of the tumor may release cells and substances that may help with killing tumor cells, reducing tumor symptoms and shrinking tumors. Proton therapy is a type of radiation therapy that can overcome some of the barriers of standard SFRT. Protons are tiny radioactive particles that can be controlled in a beam to travel up to the tumor and, compared to the particles used in standard radiotherapy, proton therapy can deliver higher doses to the tumor because smaller doses of radiation are delivered to tissues away from the tumor. This allows radiation therapy dose-escalated (continuously increasing the dose of radiation) treatment to tumors even though the tumor is near radiation sensitive organs like the colon. Giving P-SFRT with standard radiation therapy may work better in treating patients with newly diagnosed abdomino-pelvic soft tissue sarcoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06327477.
Locations matching your search criteria
United States
Illinois
Chicago
Northwestern UniversityStatus: Active
Contact: Vinai Gondi
Phone: 630-352-5350
Warrenville
Northwestern Medicine Cancer Center WarrenvilleStatus: Active
Contact: Vinai Gondi
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) for P-SFRT, which will be used as the recommended phase II dose (RP2D) for P-SFRT prior to standard fractionated radiation therapy for all abdomino-pelvic soft tissue sarcoma (APS) patients in Phase I. (Phase I – Surgically Resectable)
II. To determine the maximum tolerated dose (MTD) for P-SFRT, which will be used as the recommended phase II dose (RP2D) for P-SFRT prior to standard fractionated radiation therapy for all APS patients in Phase I. (Phase I – Surgically Unresectable)
III. To determine the efficacy of P-SFRT prior to standard fractionated radiation therapy for all APS patients in Phase II. (Phase II – Surgically Resectable)
IV. To determine the efficacy of P-SFRT prior to standard fractionated radiation therapy for all APS patients in Phase II. (Phase II – Surgically Unresectable)
SECONDARY OBJECTIVES:
I. To determine whether P-SFRT is safe when administered prior to standard fractionated radiation therapy and surgery. (Phase I - Surgically Resectable)
II. To determine whether P-SFRT is safe when administered prior to standard fractionated radiation therapy. (Phase I – Surgically Unresectable)
III. To determine rate of pathologic complete response (pCR) in patients with APS who have been treated with P-SFRT prior to standard fractionated radiation therapy and have surgically resection post study treatment. (Phase II – Surgically Resectable)
IV. To determine disease-free survival (DFS) in patients with APS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II – Surgically Resectable)
V. To determine overall survival (OS) in patients with APS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II – Surgically Resectable)
VI. To determine overall survival (OS) in patients with APS who have been treated with P-SFRT prior to standard fractionated radiation therapy. (Phase II – Surgically Unresectable)
VII. To determine disease-free survival (DFS) in patients with APS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II – Surgically Unresectable)
VIII. To determine objective response (OR) in patients with APS who have been treated with P-SFRT prior to standard fractionated radiation therapy. (Phase II – Surgically Unresectable)
OUTLINE: This is a phase I, dose-escalation study of P-SFRT followed by a phase II study.
Patients undergo P-SFRT over 1 fraction. Patients then undergo image-guided intensity modulated radiation therapy (IG-IMRT) over 25 fractions (for patients who are able to undergo surgery) or 10 fractions (for patients who are unable to undergo surgery) for 14-35 days. Patients who are able to undergo surgical resection 21 to 35 days after radiation therapy. Patients undergo blood sample collection and computed tomography (CT) throughout the trial.
After completion of study treatment, patients who were unable to undergo surgery are followed up at 30 and 90 days. Patients who were able to undergo surgery are followed up at 30 days. All patients are then followed every 90 days for up to 36 months.
Lead OrganizationNorthwestern University
Principal InvestigatorVinai Gondi
