๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-02

Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma (NCT06327477)

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Northwestern University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Northwestern University โ€” Chicago, Illinois

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Biopsy (PROCEDURE)
  • Biospecimen Collection (PROCEDURE)
  • Computed Tomography (PROCEDURE)
  • Intensity-Modulated Radiation Therapy (RADIATION)
  • Resection (PROCEDURE)
  • Spatially-fractionated Radiation Therapy (RADIATION)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Northwestern University โ€” Chicago, Illinois

๐Ÿ“ž Contact the Study Coordinator

Phone: (312) 695-1301

Email: cancer@northwestern.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—