Clinical trial · Interventional
Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.
PROSARC-2. Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects. The planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction). At the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans. The primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life. The study will be conducted in Norway, with a planned inclusion of 40 patients.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyosarcoma (LMS) | Leiomyosarcoma | ONTOLOGY_EXACT | 0.85 |
| Liposarcoma | Liposarcoma | ONTOLOGY_EXACT | 0.90 |
| Myxofibrosarcoma | Myxofibrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Pleomorphic Liposarcoma | Pleomorphic Liposarcoma | ONTOLOGY_EXACT | 0.98 |
| Pleomorphic Rhabdomyosarcoma | Pleomorphic Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Soft Tissue Sarcoma Adult | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.85 |
| Soft Tissue Sarcoma of the Trunk and Extremities | Soft Tissue Sarcoma of the Trunk and Extremities | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Definitive radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Inoperable soft tissue sarcoma
- interventionNames
- Radiation: Definitive radiotherapy
Primary outcomes (1)
- measure
- Local progression-free survival
- timeFrame
- 2 Year
- description
- Local progression-free survival is measured from the date of start of study treatment until date of local progression of the tumor that has undergone proton beam radiotherapy evaluated using RECIST v1.1 or date of death of any cause, whichever occurs first.
Secondary outcomes (5)
- measure
- Progression-free survival
- timeFrame
- Up to five years after radiation therapy
- description
- Progression-free survival is measured from the date of start of study treatment until date of progressive disease (local and/or distant) as evaluated using RECIST v1.1 or date of death of any cause, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available