NCT07169344 Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma
| NCT ID | NCT07169344 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oslo University Hospital |
| Condition | Soft Tissue Sarcoma (Excluding GIST) |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 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 110 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 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.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years of age at the time of informed consent. 2. Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible. 3. Primary tumor localized in head, neck, extremity, girdle and/or trunk wall. 4. Measurable disease according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 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 PBT. Exclusion Criteria: 1. 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. 2. 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. 3. Previous radiotherapy to the primary tumor region. 4. Patients with pacemakers and/or implanted defibrillators. 5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy. 6. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.
Contact & Investigator
Ivar Hompland, MD, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT07169344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma (Excluding GIST). 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 NCT07169344 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 NCT07169344 currently recruiting?
Yes, NCT07169344 is actively recruiting participants. Contact the research team at martineko@ous-hf.no for enrollment information.
Where is the NCT07169344 trial being conducted?
This trial is being conducted at Bergen, Norway, Oslo, Norway, Tromsø, Norway, Trondheim, Norway.
Who is sponsoring the NCT07169344 clinical trial?
NCT07169344 is sponsored by Oslo University Hospital. The principal investigator is Ivar Hompland, MD, PhD at Oslo University Hospital. The trial plans to enroll 110 participants.