Dose‑escalated, short‑course proton radiation for inoperable 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-2 is a single-arm, open-label phase II multicenter trial in Norway testing dose-escalated, hypofractionated proton beam therapy for patients with inoperable soft tissue sarcoma. Participants will receive 56 Gy in 16 fractions over four weeks with an optional central tumor boost up to 80 Gy, and will be followed for tumor control and survival outcomes. The trial plans to enroll about 40 patients across major Norwegian sarcoma centers and will collect blood and imaging biomarkers and tumor DNA for translational research. The primary endpoint is 2-year local progression-free survival, with secondary endpoints including overall survival, progression-free survival, and radiologic response.

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 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.

Where it's running

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

Study contacts

• Principal investigator: Ivar Hompland, MD, PhD — Oslo University Hospital
• Study coordinator: Martine Karlsen 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.