NCT07173972 Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.
| NCT ID | NCT07173972 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oslo University Hospital |
| Condition | Soft Tissue Sarcoma (STS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2029-01-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-01-26 with a primary completion date of 2029-01-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years of age at the time of informed consent. 2. Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST). 3. Measurable disease according to RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 5. For patients with metastatic disease a life-expectancy greater than 2 years should be expected. 6. Before patient registration, written informed consent must be given according to national and local regulations. 7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for Proton Beam radiotherapy. Exclusion Criteria: 1. 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. 2. Previous radiotherapy to the tumor site. 3. Patients with pacemakers and/or implanted defibrillators. 4. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator. 5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.
Contact & Investigator
Ivar Hompland, MD, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT07173972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma (STS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07173972 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07173972 currently recruiting?
Yes, NCT07173972 is actively recruiting participants. Contact the research team at martineko@ous-hf.no for enrollment information.
Where is the NCT07173972 trial being conducted?
This trial is being conducted at Bergen, Norway, Oslo, Norway.
Who is sponsoring the NCT07173972 clinical trial?
NCT07173972 is sponsored by Oslo University Hospital. The principal investigator is Ivar Hompland, MD, PhD at Oslo University Hospital. The trial plans to enroll 40 participants.