A Phase 2 interventional study of preoperative and Quality of life in Soft Tissue Sarcoma (Excluding GIST), Soft Tissue Sarcoma Adult and Soft Tissue Sarcoma of the Trunk and Extremities, sponsored by Oslo University Hospital. Recruiting at 4 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment
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.
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.
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's planned enrollment of 110 is above the median of 40 across 1,255 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will receive either proton radiotherapy or x-ray radiotherapy preoperatively, 2.85 Gy x 15.
Radiation: preoperative · Other: Quality of life · Other: Functional outcome
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.
Questionnaire
Questionnaire
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).
Time frame: 120 days from surgery
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Perioperative
Health-related quality of life
Change from baseline in EORTC QLQ-C30 scores.
Time frame: Up to five years after radiation therapy
Functional outcome
Changes from baseline in Musculoskeletal Tumor Society Rating Scale (MSTS)
Time frame: Up to five years after radiation therapy
Functional outcome
Changes from baseline in the Toronto Extremity Salvage Score (TESS).
Time frame: Up to five years after radiation therapy
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2029, 36 months after the start.
Of 198 non-industry phase 2 interventional studies under Sarcoma, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 46 and three quarters within 91. This study's planned 36 months is below that.
Counting every sponsor, half of 227 studies reached it within 66 months; a quarter within 43 and three quarters within 92.
How these figures are worked out, and which studies are left out of them.
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