Status:
NOT_YET_RECRUITING
Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Haukeland University Hospital
St. Olavs Hospital
Conditions:
Soft Tissue Sarcoma (STS)
Soft Tissue Sarcoma Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 radiatio...
Detailed Description
The objective of the PROSARC-2 trial is to investigate whether dose-escalated hypofractionated, definitive, proton beam therapy (PBT) can result in better local control in soft tissue sarcoma (STS). P...
Eligibility Criteria
Inclusion
- ≥ 18 years of age 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
- For patients with metastatic disease a life-expectancy greater than 2 years should be expected.
- 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 Proton Beam radiotherapy.
Exclusion
- Patients with a 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 tumor site.
- 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.
- Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2035
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07173972
Start Date
November 1 2025
End Date
November 1 2035
Last Update
September 15 2025
Active Locations (2)
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1
Haukeland University Hospital
Bergen, Norway
2
Oslo University Hospital
Oslo, Norway