nctId: NCT06327477 id: NU 23S01 id: NCI-2024-01927 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STU00220015 id: NU 23S01 type: OTHER domain: Northwestern University id: P30CA060553 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA060553 briefTitle: Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma overallStatus: RECRUITING date: 2024-04-02 date: 2027-07-01 date: 2028-07-01 date: 2024-03-25 date: 2024-04-26 name: Northwestern University class: OTHER name: National Cancer Institute (NCI) briefSummary: 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. conditions: Retroperitoneal Sarcoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Intensity-Modulated Radiation Therapy name: Resection name: Spatially-fractionated Radiation Therapy measure: Recommended phase II dose (Phase I) measure: Pathological complete response (Phase II) measure: Incidence of adverse events (Phase I) measure: Overall response rate (ORR) (Phase II) measure: Progression-free survival (PFS) (Phase II) measure: Overall survival (OS) ( (Phase II) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Seth M. Pollack role: CONTACT phone: 312-695-6180 name: Seth M. Pollack, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False