RecruitingPhase 2NCT07169344

Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma

PROSARC-1. Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.


Sponsor

Oslo University Hospital

Enrollment

110 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to investigate whether a personalized selection of patients with localized soft tissue sarcoma for preoperative proton radiation therapy can reduce long-term radiation side effects without increasing surgical complications or reducing the effectiveness of the treatment. Two radiation plans will be created for each patient-one for protons and one for photons-and through a national meeting, we will determine which type of radiation therapy each patient will receive. The radiation dose will be the same for both photons and protons. The primary endpoint is surgical complications 120 days after surgery. Secondary endpoints include overall survival, local recurrence-free survival, disease-free survival, side effects, and quality of life. Furthermore, the study will investigate biomarkers that may predict response to radiation therapy, including changes in the tumor's genetic material (DNA), measurement of various molecules in the bloodstream, and the tumor's appearance on MRI scans. The study will be conducted in Norway, with a planned inclusion of 110 patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of radiation therapy — proton therapy and standard X-ray radiation — given over 3 weeks before surgery in people with soft tissue sarcoma (a cancer of the muscles, fat, tendons, or connective tissue). The study aims to see whether shorter, more intense pre-operative radiation (hypofractionation) is as effective and less burdensome than longer traditional courses. **You may be eligible if...** - You are 18 or older - You have been diagnosed with soft tissue sarcoma located in the head, neck, arms, legs, or trunk wall - Your cancer has not spread to other parts of the body - You are in adequate overall health (ECOG 0–2) - You are able to travel to Bergen or Oslo for treatment if assigned to proton therapy **You may NOT be eligible if...** - You have rhabdomyosarcoma or Ewing sarcoma (specific subtypes are excluded, though pleomorphic rhabdomyosarcoma is allowed) - Your cancer has spread (metastasized) to other organs or areas - You have had prior radiation to the same area 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

RADIATIONpreoperative

The radiotherapy will be delivered 2.85 Gy x 15 for both x-ray or proton radiotherapy. A comparative doseplan will decide if the patient will receive proton og x-ray radiotherapy.

OTHERQuality of life

Questionnaire

OTHERFunctional outcome

Questionnaire


Locations(4)

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital

Oslo, Norway

University Hospital of North Norway

Tromsø, Norway

St. Olavs University Hospital

Trondheim, Norway

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NCT07169344


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