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.
≥ 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.
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.
Single group
preoperative
RadiationThe 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 life
Other interventionQuestionnaire
Functional outcome
Other interventionQuestionnaire
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).
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
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.
Overall survival
Overall survival is measured from the date of start of study treatment until date of death of any cause.
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.
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Oslo University Hospital
Lead sponsor
Haukeland University Hospital
Collaborator
University Hospital of North Norway
Collaborator
St. Olavs Hospital
Collaborator
