Actively Recruiting
Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma
Led by Oslo University Hospital · Updated on 2026-01-28
110
Participants Needed
4
Research Sites
509 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
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.
CONDITIONS
Official 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...
- At least 18 years old at the 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 according to RECIST v1.1 criteria
- ECOG performance status of 0, 1, or 2
- Written informed consent given before registration
- Ability to complete questionnaires and comply with study procedures, including travel to Bergen or Oslo for proton therapy
You will not qualify if you...
- Presence of locoregional or distant metastasis by CT or MRI at diagnosis (lung nodules under 10 mm of uncertain cause may be allowed)
- Prior or concurrent malignant diseases that could interfere with trial safety or effectiveness, except for breast cancer on hormonal therapy or prostate cancer on hormone support
- Previous radiotherapy to the tumor area
- Having pacemakers or implanted defibrillators
- Systemic cancer therapy within 14 days before starting radiotherapy
- Inability to give informed consent or comply with study rules as judged by the investigator
AI-Screening
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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
CONTACT
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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