Status:
NOT_YET_RECRUITING
Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Haukeland University Hospital
University Hospital of Northern Norway, Tromsø, Norway
Conditions:
Soft Tissue Sarcoma (Excluding GIST)
Soft Tissue Sarcoma Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
The objective of the PROSARC-1 trial is to investigate whether a national personalized approach with proton beam therapy (PBT) to selected soft tissue sarcoma (STS) patients can reduce long-term toxic...
Eligibility Criteria
Inclusion
- ≥ 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2035
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07169344
Start Date
November 1 2025
End Date
November 1 2035
Last Update
September 11 2025
Active Locations (4)
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1
Haukeland University Hospital
Bergen, Norway
2
Oslo University Hospital
Oslo, Norway
3
University Hospital of North Norway
Tromsø, Norway
4
St. Olavs University Hospital
Trondheim, Norway