Actively Recruiting
Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.
Led by Oslo University Hospital · Updated on 2026-01-28
40
Participants Needed
2
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 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.
CONDITIONS
Official Title
Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of informed consent
- Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST)
- Measurable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy greater than 2 years for patients with metastatic disease
- Written informed consent given according to national and local regulations
- Ability to complete patient questionnaires and comply with study procedures, including travel to Bergen or Oslo for proton beam radiotherapy
You will not qualify if you...
- Prior or concurrent malignant disease that could interfere with safety or efficacy assessment, except for breast cancer requiring hormonal treatment or prostate cancer requiring LHRH agonists with or without androgens
- Previous radiotherapy to the tumor site
- Having a pacemaker and/or implanted defibrillator
- Unable to give informed consent or comply with study regulations as judged by the investigator
- Received systemic cancer therapy (chemotherapy, targeted therapy, or immune therapy) within 14 days before the first radiotherapy fraction
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Haukeland University Hospital
Bergen, Norway
Not Yet Recruiting
2
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
M
Martine Karlsen 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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