Last reviewed · How we verify
NCT07169344: PROSARC-1
Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma
Phase 2 trial testing preoperative in Soft Tissue Sarcoma (Excluding GIST) in 110 participants. Currently enrolling.
26 January 2029
Quick facts
| Lead sponsor | Oslo University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 26 January 2026 |
| Primary completion | 26 January 2029 |
| Estimated completion | 1 November 2035 |
| Sites | 4 locations across Norway |
Drugs / interventions tested
- preoperative
- Quality of life
- Functional outcome
Conditions studied
- Soft Tissue Sarcoma (Excluding GIST) — all drugs for Soft Tissue Sarcoma (Excluding GIST) →
- Soft Tissue Sarcoma Adult — all drugs for Soft Tissue Sarcoma Adult →
- Soft Tissue Sarcoma of the Trunk and Extremities — all drugs for Soft Tissue Sarcoma of the Trunk and Extremities →
- Synovial Sarcomas — all drugs for Synovial Sarcomas →
Sponsor
Oslo University Hospital
Who can join
18 and older, any sex, with Soft Tissue Sarcoma (Excluding GIST) or Soft Tissue Sarcoma Adult. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07169344
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07169344 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
- Last refreshed: 28 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07169344.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing