Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma

Retroperitoneal Sarcoma Clinical Trial

Official title: First-in-Human Phase I and II Study to Determine Safety and Efficacy of Proton-Spatially Fractionated Radiotherapy (P-SFRT) in Retroperitoneal Soft Tissue Sarcoma

Status Recruiting

Clinical Trial Summary

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 retroperitoneal 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 retroperitoneal soft tissue sarcoma.

Clinical Trial Description

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 and surgical intervention for retroperitoneal sarcoma (RPS). (Phase I) II. To determine the efficacy of P-SFRT prior to standard fractionated radiation therapy and surgical intervention for RPS. (Phase II)

SECONDARY OBJECTIVES:

I. To determine whether P-SFRT is safe when administered prior to standard fractionated radiation therapy and surgery for RPS. (Phase I) II. To determine progression-free survival (PFS) in patients with RPS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II) III. To determine overall survival (OS) in patients with RPS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II) IV. To determine objective response (OR) in patients with RPS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II)

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 and then undergo image-guided intensity modulated radiation therapy (IG-IMRT) over 25-28 fractions for 35 to 42 days. Patients undergo surgical resection 21 to 35 days after radiation therapy. Patients undergo blood sample collection during screening and on study. Patients also undergo biopsy during screening and computed tomography (CT) on study and on follow up.

After completion of study treatment, patients are followed up at 30 and 90 days after surgery, and then up to 36 months. ;

Related Conditions & MeSH terms

• Retroperitoneal Sarcoma
• Sarcoma

• NCT number: NCT06327477
• Study type: Interventional
• Source: Northwestern University
• Contact: Study Coordinator
• Phone: 3126951301
• Email: cancer@northwestern.edu
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2, 2024
• Completion date: July 1, 2028