Soft Tissue Sarcoma (Excluding GIST)Phase 2PROSARC-1NCT07169344
Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma
A Phase 2 study testing preoperative, Quality of life and Functional outcome in people with Soft Tissue Sarcoma (Excluding GIST) and Soft Tissue Sarcoma Adult, run by Oslo University Hospital at 4 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma of the Trunk and Extremities
- What is being tested?
- preoperative, Quality of life and Functional outcome
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesNorway
- Study dates
- 26 Jan 2026to 1 Nov 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at the time of informed consent.
- Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible.
- Primary tumor localized in head, neck, extremity, girdle and/or trunk wall.
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Before patient registration, written informed consent must be given according to national and local regulations.
- Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for PBT.
Who cannot join
- 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.
- 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.
- Previous radiotherapy to the primary tumor region.
- Patients with pacemakers and/or implanted defibrillators.
- Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.
- Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway4 sites, 4 recruiting
- Not yet recruiting
Haukeland University Hospital
Bergen
Dorota Goplen, MD, PhD, +4755975000, dorota.katarzyna.pazdyk.goplen@helse-bergen.no
- Recruiting
Oslo University Hospital
Oslo
Ivar Hompland, MD, PhD, +4791698933, ivahom@ous-hf.no
- Not yet recruiting
University Hospital of North Norway
Tromsø
Thomas Kilvær, MD, PhD, +4777626000
- Not yet recruiting
St. Olavs University Hospital
Trondheim
Heidi Knobel, MD, PhD, +4772573000
About this study
Official title: 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.
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.
Read the detailed description
The objective of the PROSARC-1 trial is to investigate whether a national personalized approach with proton beam therapy (PBT) to selected soft tissue sarcoma (STS) patients can reduce long-term toxicity without increasing surgical complications or compromising local control. PROSARC-1 is a single arm, open-label, multicenter phase II trial initiated at Department of Oncology, Oslo University Hospital (OUS). The main inclusion criterion is patients with newly diagnosed STS of the head, neck, extremity or trunk wall. The primary endpoint is major wound complications (MVC) occurring within the first 120 days after surgery. We expect to include 110 patients over three years and all patients will be followed for up to five years. All the sarcoma centers in Norway participate in the study: OUS; Haukeland University hospital (HUH); St Olavs Hospital (SOH) and the University Hospital of North-Norway (UNN). The indication for preoperative radiotherapy (RT) will be decided in the sarcoma multidisciplinary (MDT) meeting at each center. For included patients, one X-ray radiotherapy (XRT) and one PBT plan will be made for comparison. A weekly national sarcoma radiotherapy meeting will compare the plans and recommend XRT or PBT treatment based on a careful clinical evaluation, also considering thresholds based on the toxicity grade. The prescribed dose is standard 42.75 Gy in 15 fractions over 3 weeks for both XRT and PBT.
The PROSARC-1 trial includes translational radiomic research, where we aim to elucidate underlying mechanisms related to radiotherapy effect. To facilitate future biomarker studies for personalized therapy we will collect excess tumor tissue, whole blood, plasma and serum.
- Conditions
- Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma of the Trunk and Extremities, Synovial Sarcomas, Leiomyosarcoma, Undifferentiated Pleomorphic Sarcoma (UPS)
- Being tested
- preoperative, Quality of life, Functional outcome
- Keywords
- Soft tissue sarcoma, proton radiotherapy, x-ray radiotherapy, surgical complications
- Medical subject headings
- Sarcoma, Sarcoma, Synovial, Leiomyosarcoma, Histiocytoma, Malignant Fibrous, Dermatofibrosarcoma, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperativeRadiation
The radiotherapy will be delivered 2.85 Gy x 15 for both x-ray or proton radiotherapy. A comparative doseplan will decide if the patient will receive proton og x-ray radiotherapy.
Quality of lifeOther
Questionnaire
Functional outcomeOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue sarcoma | Experimental | All patients will receive either proton radiotherapy or x-ray radiotherapy preoperatively, 2.85 Gy x 15. Receives: Radiation: preoperative; Other: Quality of life; Other: Functional outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major surgical complications
The criteria that define a major wound complication include the following:
- Secondary operation(s) required for wound treatment (e.g. debridement, secondary closure procedures such as rotationplasty, vacuum-assisted closure (VAC), free flaps or skin grafts);
- Readmission to hospital for wound care;
- Invasive procedures required for wound care (drainage of hematoma, seroma or infected wound collection);
- Deep wound packing required at any time (deep packing defined as packing deep to dermis in an area of dehisced wound) to an area of wound measuring at least 2 cm in length;
- Prolonged dressing changes, including packing of the wound for greater than six weeks from wound breakdown;
- Repeat surgery for revision of a split thickness skin graft or requirement for wet dressings for longer than four weeks. (It is permissible for a patient to protect a totally epithelialized skin graft with a dry dressing without declaring a major wound complication).
Measured: 120 days from surgery
Secondary outcomes (8)
Local recurrence-free survival
Local recurrence-free survival is measured from the date of start of study treatment until date of local relapse as evaluated using RECIST v1.1 or date of death of any cause, whichever occurs first
Measured: Up to five years after radiation therapy.
Disease-free survival
is measured from the date of start of study treatment until date of progressive disease as evaluated using RECIST v1.1, date of disease recurrence (local relapse or distant metastasis) or date of death of any cause, whichever occurs first.
Measured: Up to five years after radiation therapy
Overall survival
Overall survival is measured from the date of start of study treatment until date of death of any cause.
Measured: Up to five years after radiation therapy
Overall response rate, defined as partial or complete response using RECIST v1.1
Radiological response will be assessed using MRI and/or CT of the primary tumor.
Measured: Up to five years after radiation therapy
Pathological response
pathological response assessed by: Percentage of residual viable tumor cells; Mitotic index; and percentages of the following components of the resected tumor mass: necrosis, hemorrhage, sclerosis, sclerohyalinosis, fibrohistiocytic reaction with hemosiderin.
Measured: Perioperative
Health-related quality of life
Change from baseline in EORTC QLQ-C30 scores.
Measured: Up to five years after radiation therapy
Functional outcome
Changes from baseline in Musculoskeletal Tumor Society Rating Scale (MSTS)
Measured: Up to five years after radiation therapy
Functional outcome
Changes from baseline in the Toronto Extremity Salvage Score (TESS).
Measured: Up to five years after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start26 Jan 2026
- Primary completion26 Jan 2029 (estimated)
- Study completion1 Nov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma (Excluding GIST)Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Responsible party
- Principal investigator, Ivar Hompland, Oslo University Hospital
- Investigators
- Ivar Hompland, MD, PhD, Principal investigator, Oslo University HospitalKjetil Boye, MD, PhD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169344
- Sponsor's protocol ID
- 915811
- Acronym
- PROSARC-1
- Status last verified
- Jan 2026
- First submitted
- 4 Aug 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07169344
- Acronym / sponsor ID
- PROSARC-1 / 915811
- Conditions
- Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma of the Trunk and Extremities, Synovial Sarcomas, Leiomyosarcoma, Undifferentiated Pleomorphic Sarcoma (UPS)
- Keywords
- Soft tissue sarcoma, proton radiotherapy, x-ray radiotherapy, surgical complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital of North Norway, St. Olavs Hospital
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 26 Jan 2029 (estimated)
- Study completion
- 1 Nov 2035 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the PROSARC-1 trial is to investigate whether a national personalized approach with proton beam therapy (PBT) to selected soft tissue sarcoma (STS) patients can reduce long-term toxicity without increasing surgical complications or compromising local control. PROSARC-1 is a single arm, open-label, multicenter phase II trial initiated at Department of Oncology, Oslo University Hospital (OUS). The main inclusion criterion is patients with newly diagnosed STS of the head, neck, extremity or trunk wall. The primary endpoint is major wound complications (MVC) occurring within the first 120 days after surgery. We expect to include 110 patients over three years and all patients will be followed for up to five years. All the sarcoma centers in Norway participate in the study: OUS; Haukeland University hospital (HUH); St Olavs Hospital (SOH) and the University Hospital of North-Norway (UNN). The indication for preoperative radiotherapy (RT) will be decided in the sarcoma multidisciplinary (MDT) meeting at each center. For included patients, one X-ray radiotherapy (XRT) and one PBT plan will be made for comparison. A weekly national sarcoma radiotherapy meeting will compare the plans and recommend XRT or PBT treatment based on a careful clinical evaluation, also considering thresholds based on the toxicity grade. The prescribed dose is standard 42.75 Gy in 15 fractions over 3 weeks for both XRT and PBT.
The PROSARC-1 trial includes translational radiomic research, where we aim to elucidate underlying mechanisms related to radiotherapy effect. To facilitate future biomarker studies for personalized therapy we will collect excess tumor tissue, whole blood, plasma and serum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soft tissue sarcoma | Experimental | Radiation: preoperative, Other: Quality of life, Other: Functional outcomeAll patients will receive either proton radiotherapy or x-ray radiotherapy preoperatively, 2.85 Gy x 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age at the time of informed consent.
- Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible.
- Primary tumor localized in head, neck, extremity, girdle and/or trunk wall.
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Key exclusion criteria (6 listed)
- 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.
- 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.
- Previous radiotherapy to the primary tumor region.
- Patients with pacemakers and/or implanted defibrillators.
- Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperativeThe radiotherapy will be delivered 2.85 Gy x 15 for both x-ray or proton radiotherapy. A comparative doseplan will decide if the patient will receive proton og x-ray radiotherapy. | Radiation | Soft tissue sarcoma |
| Quality of lifeQuestionnaire | Other | Soft tissue sarcoma |
| Functional outcomeQuestionnaire | Other | Soft tissue sarcoma |
Primary outcome
Major surgical complications
Time frame: 120 days from surgery
The criteria that define a major wound complication include the following: * Secondary operation(s) required for wound treatment (e.g. debridement, secondary closure procedures such as rotationplasty, vacuum-assisted closure (VAC), free flaps or skin grafts); * Readmission to hospital for wound care; * Invasive procedures required for wound care (drainage of hematoma, seroma or infected wound collection); * Deep wound packing required at any time (deep packing defined as packing deep to dermis in an area of dehisced wound) to an area of wound measuring at least 2 cm in length; * Prolonged dressing changes, including packing of the wound for greater than six weeks from wound breakdown; * Repeat surgery for revision of a split thickness skin graft or requirement for wet dressings for longer than four weeks. (It is permissible for a patient to protect a totally epithelialized skin graft with a dry dressing without declaring a major wound complication).
8 secondary outcomes
Local recurrence-free survival
Time frame: Up to five years after radiation therapy.
Disease-free survival
Time frame: Up to five years after radiation therapy
Overall survival
Time frame: Up to five years after radiation therapy
Overall response rate, defined as partial or complete response using RECIST v1.1
Time frame: Up to five years after radiation therapy
Pathological response
Time frame: Perioperative
Health-related quality of life
Time frame: Up to five years after radiation therapy
Functional outcome
Time frame: Up to five years after radiation therapy
Functional outcome
Time frame: Up to five years after radiation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Soft Tissue Sarcoma (Excluding GIST)
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Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma (Excluding GIST)
Not yet recruitingPhase 2
Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Advanced STS
Soft Tissue Sarcoma (Excluding GIST)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivar Hompland, MD, PhD principal investigator
Oslo University Hospital
Kjetil Boye, MD, PhD study director
Oslo University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing preoperative, Quality of life and Functional outcome in people with Soft Tissue Sarcoma (Excluding GIST) and Soft Tissue Sarcoma Adult, run by Oslo University Hospital at 4 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martine Karlsen Ødegaard, Cancer Nurse (+47 99562019, martineko@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major surgical complications (time frame: 120 days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.