Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma
Recruiting now · Phase 2
Conditions studied: Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma of the Trunk and Extremities, Synovial Sarcomas, Leiomyosarcoma, Undifferentiated Pleomorphic Sarcoma (UPS), Myxofibrosarcoma (MFS), Liposarcoma, Pleomorphic Rhabdomyosarcoma
In brief
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.
Key facts
- Study ID
- NCT07169344
- Run by
- Oslo University Hospital
- People needed
- 110
- Starts
- 2026-01-26
- Expected to finish
- 2035-11-01
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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.
You may not qualify if…
- 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.
- 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.
- Patients with pacemakers and/or implanted defibrillators.
- Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.
- Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.
Where it is running
- Oslo University Hospital — Oslo, Norway (enrolling)
- Haukeland University Hospital — Bergen, Norway
- University Hospital of North Norway — Tromsø, Norway
- St. Olavs University Hospital — Trondheim, Norway
Full record on ClinicalTrials.gov
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