RecruitingPhase 1Phase 2NCT06327477

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

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


Sponsor

Northwestern University

Enrollment

28 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specialized type of radiation therapy called proton spatially fractionated radiotherapy (proton GRID therapy) combined with standard radiation for large retroperitoneal soft tissue sarcomas — rare tumors found in the back of the abdomen. Because these tumors are often very large and near vital organs, they're difficult to treat with standard radiation alone. The GRID approach delivers non-uniform doses that may be more effective at killing large tumors while protecting surrounding tissue. **You may be eligible if...** - You are 18 or older - You have a newly diagnosed retroperitoneal soft tissue sarcoma confirmed by biopsy - You have not received any prior treatment for this sarcoma - Your tumor is at least 3 cm in diameter and measurable by imaging - Your general health is good (ECOG 0–1 or Karnofsky over 70%) - Your blood counts meet required thresholds **You may NOT be eligible if...** - You have had prior chemotherapy, radiation, or surgery for this sarcoma - You have significant heart, kidney, or liver problems - You are pregnant - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT06327477


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