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
Northwestern University
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.
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-fre…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have newly diagnosed, histologically or cytologically confirmed, untreated retroperitoneal soft tissue sarcoma * The soft-tissue sarcoma tumor must be at least 3 cm in diameter * Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. * Patients must be age ≥ 18 years on day of signing any informed consent documents * Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale or \>70% on the Karnofsky Scale * Leukocytes (white blood…
Interventions
- ProcedureBiopsy
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- RadiationIntensity-Modulated Radiation Therapy
Undergo IG-IMRT
- ProcedureResection
Undergo surgical resection
- RadiationSpatially-fractionated Radiation Therapy
Undergo P-SFRT
Location
- Northwestern UniversityChicago, Illinois