Three-week preoperative proton versus X-ray radiotherapy for localized soft tissue sarcoma
PROSARC-1. Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.
This trial tests whether selecting proton rather than standard X‑ray radiotherapy before surgery for adults with localized soft tissue sarcoma can lower long-term radiation side effects without increasing surgical complications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Bergen and 3 other locations) |
| Trial ID | NCT07169344 on ClinicalTrials.gov |
What this trial studies
PROSARC-1 is a single-arm, open-label, multicenter phase II trial in Norway enrolling adults with newly diagnosed localized soft tissue sarcoma of the head, neck, extremity or trunk wall. For each patient, both a proton and an X‑ray radiotherapy plan are generated and a national sarcoma radiotherapy meeting recommends which modality to use based on dosimetry and predefined toxicity thresholds; the prescribed dose is 42.75 Gy delivered in 15 fractions over three weeks for either modality. The primary endpoint is major wound complications within 120 days after surgery, with secondary endpoints including overall survival, local recurrence‑free survival, disease‑free survival, side effects, quality of life, and translational biomarker and radiomic studies. Up to 110 patients will be enrolled across Norwegian sarcoma centers and followed for up to five years to capture long‑term outcomes.
Who should consider this trial
Good fit: Adults (≥18) with newly diagnosed, localized soft tissue sarcoma of the head, neck, extremity, girdle or trunk wall, measurable disease, ECOG 0–2, and ability to complete study procedures including travel for proton treatment if selected are ideal candidates.
Not a fit: Patients with locoregional or distant metastases, tumor types excluded by the protocol (e.g., Ewing sarcoma), prior malignancies that interfere with safety or efficacy assessments, or those unable to travel for proton therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients could experience fewer long-term radiation side effects while maintaining effective tumor control.
How similar studies have performed: Proton therapy has reduced normal‑tissue dose in other cancers and retrospective series in sarcoma suggest potential benefits, but randomized evidence and formal personalized-selection approaches in soft tissue sarcoma remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bergen and 3 other locations
- Haukeland University Hospital — Bergen, Norway (Not_yet_recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Not_yet_recruiting)
- St. Olavs University Hospital — Trondheim, Norway (Not_yet_recruiting)
Study contacts
- Principal investigator: Ivar Hompland, MD, PhD — Oslo University Hospital
- Study coordinator: Martine Karlsen Ødegaard, Cancer Nurse
- Email: martineko@ous-hf.no
- Phone: +47 99562019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.