Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma

NCT07169344 | Recruiting Phase 2 DMC

• 1 other identifier: 915811
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Soft Tissue Sarcoma Adult; Soft Tissue Sarcoma of the Trunk and Extremities; Synovial Sarcomas; Leiomyosarcoma; Undifferentiated Pleomorphic Sarcoma (UPS); Myxofibrosarcoma (MFS); Pleomorphic Rhabdomyosarcoma; Soft Tissue Sarcoma (Excluding GIST); Liposarcoma

Keywords

Soft tissue sarcoma; proton radiotherapy; x-ray radiotherapy; surgical complications

Outcome Measures

Primary Outcomes (1)

• 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).

  120 days from surgery

Secondary Outcomes (8)

• Local recurrence-free survival

  Up to five years after radiation therapy.

• Disease-free survival

  Up to five years after radiation therapy

• Overall survival

  Up to five years after radiation therapy

• Overall response rate, defined as partial or complete response using RECIST v1.1

  Up to five years after radiation therapy

• Pathological response

  Perioperative

Study Arms (1)

Soft tissue sarcoma

EXPERIMENTAL

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

Interventions

preoperative RADIATION

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.

Soft tissue sarcoma

Quality of life OTHER

Questionnaire

Soft tissue sarcoma

Functional outcome OTHER

Questionnaire

Soft tissue sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Haukeland University Hospital: collaborator
• University Hospital of Northern Norway, Tromsø, Norway: collaborator
• St. Olavs Hospital: collaborator

Study Sites (4)

Haukeland University Hospital

Bergen, Norway

NOT YET RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

University Hospital of North Norway

Tromsø, Norway

NOT YET RECRUITING

St. Olavs University Hospital

Trondheim, Norway

NOT YET RECRUITING

MeSH Terms

Conditions

Sarcoma; Sarcoma, Synovial; Leiomyosarcoma; Histiocytoma, Malignant Fibrous; Dermatofibrosarcoma; Liposarcoma

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Histiocytoma; Neoplasms, Fibrous Tissue; Fibrosarcoma; Neoplasms, Adipose Tissue

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ivar Hompland, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Kjetil Boye, MD, PhD

  Oslo University Hospital

  STUDY DIRECTOR

Central Study Contacts

Martine Karlsen Ødegaard, Cancer Nurse

CONTACT

+47 99562019; martineko@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, MD, PhD

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: September 11, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): January 26, 2029
• Study Completion (Estimated): November 1, 2035
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

NO (4)