RecruitingPhase 2NCT07173972

Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.

PROSARC-2. Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.


Sponsor

Oslo University Hospital

Enrollment

40 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects. The planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction). At the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans. The primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life. The study will be conducted in Norway, with a planned inclusion of 40 patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing high-dose, shorter-course proton beam radiation therapy (a precise form of radiation) for people with soft tissue sarcoma (a type of tumor in muscles, fat, or connective tissue) who cannot have surgery. Proton therapy is more targeted than standard X-ray radiation and may reduce side effects. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of soft tissue sarcoma (including GIST) - Your tumor is visible on scans and you are in reasonable physical condition (ECOG 0–2) - If you have metastatic disease, your life expectancy is greater than 2 years - You can travel to Bergen or Oslo for treatment **You may NOT be eligible if...** - You have another active cancer that could interfere with the study - You are unable to fill out questionnaires or follow study procedures 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONDefinitive radiotherapy

The prescribed dose is 56 Gray (Gy) in 16 fractions over 4 weeks (14 Gy per week) with a maximum dose-escalation to the tumor core of 80 Gy (5 Gy per fraction).


Locations(2)

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital

Oslo, Norway

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07173972


Related Trials