Three-week preoperative proton versus X-ray radiotherapy for localized soft tissue sarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Oslo University Hospital
  Oslo, Norway Recruiting
• Haukeland University Hospital
  Bergen, Norway Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.