Actively Recruiting
PROSARC-1: Personalized 3-week Preoperative Proton or X-ray Radiotherapy for Localized Soft Tissue Sarcoma in a Multicenter Phase II Trial
Led by Oslo University Hospital · Updated on 2026-01-28
110
Participants Needed
4
Research Sites
352 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
H
Haukeland University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a personalized approach using proton beam therapy (PBT) for patients with localized soft tissue sarcoma can reduce long-term radiation side effects without increasing surgical complications or affecting treatment effectiveness. This phase II trial includes patients with newly diagnosed soft tissue sarcoma in the head, neck, extremity, girdle, or trunk wall areas. The study also investigates biomarkers to predict response to radiation therapy by analyzing tumor DNA, blood molecules, and MRI scans. Each participant will have two radiation plans created—one using protons and one using X-rays (photons). A weekly national meeting of sarcoma specialists will review these plans and recommend either proton or X-ray radiotherapy based on clinical evaluation and toxicity thresholds. Treatment involves a standard dose of 42.75 Gy delivered in 15 fractions over 3 weeks before surgery. The study includes collection of tumor tissue, blood, plasma, and serum for further research. Participants will be followed up to five years after treatment. Researchers will monitor surgical complications within 120 days post-surgery, as well as overall survival, disease-free survival, local recurrence-free survival, response rates, quality of life, and functional outcomes. Patients will complete questionnaires and attend scheduled assessments during the study period, which aims to include 110 patients across multiple centers in Norway.
CONDITIONS
Brief Title
Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Histological diagnosis of soft tissue sarcoma excluding rhabdomyosarcoma and Ewing sarcoma; pleomorphic rhabdomyosarcomas are allowed
- Primary tumor located in head, neck, extremity, girdle, or trunk wall
- Measurable disease per RECIST v1.1 criteria
- ECOG performance status 0, 1, or 2
- Written informed consent given according to regulations
- Ability to complete questionnaires and comply with study procedures, including travel for proton beam therapy
You will not qualify if you...
- Presence of locoregional or distant metastasis by CT or MRI at diagnosis, except lung nodules smaller than 10 mm with uncertain cause
- Prior or concurrent malignant disease that may interfere with trial safety or efficacy assessment, except certain breast or prostate cancers under hormonal treatment
- Previous radiotherapy to the primary tumor area
- Presence of pacemakers or implanted defibrillators
- Systemic cancer therapy within 14 days before starting radiotherapy
- Inability to give informed consent or comply with study regulations as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive preoperative radiotherapy with either proton beam therapy or x-ray radiotherapy, delivered in 15 fractions over 3 weeks based on a comparative dose plan.
15 visits for radiotherapy sessions
Duration - Up to 5 years
Participants are followed after surgery to monitor for major wound complications and assess long-term outcomes including local recurrence, survival, quality of life, and functional status.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 4 locations
1
Haukeland University Hospital
Bergen, Norway
Not Yet Recruiting
2
Oslo University Hospital
Oslo, Norway
Actively Recruiting
3
University Hospital of North Norway
Tromsø, Norway
Not Yet Recruiting
4
St. Olavs University Hospital
Trondheim, Norway
Not Yet Recruiting
Research Team
M
Martine Karlsen Ødegaard, Cancer Nurse
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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