NCT07169344RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 26 Jan 2026
- Primary completion date
- 26 Jan 2029
- Lead sponsor
- Oslo University Hospital
- Diseases
- Sarcoma
- NCT number
- NCT07169344
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 110
- From 26 Jan 2026 to the primary completion date, 26 Jan 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.
- Previous radiotherapy to the primary tumor region.
- Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.
Other
- Locoregional or distant metastasis as assessed by CT and/or MRI at time of diagnosis. Patients with lung nodules \<10 mm of uncertain etiology may be included.
- Patients with pacemakers and/or implanted defibrillators.
- Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.
Who the study is looking for
- ≥ 18 years of age at the time of informed consent.
- Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible.
- Primary tumor localized in head, neck, extremity, girdle and/or trunk wall.
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Before patient registration, written informed consent must be given according to national and local regulations.
- Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for PBT.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Not yet recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| University Hospital of North Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Not yet recruiting |
| St. Olavs University Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.