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

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

Interventions

RADIATION

preoperative

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.

OTHER

Quality of life

Questionnaire

OTHER

Functional outcome

Questionnaire

Sponsors & Collaborators

• Haukeland University Hospital

  collaborator OTHER

• University Hospital of Northern Norway, Tromsø, Norway

  collaborator UNKNOWN

• St. Olavs Hospital

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Ivar Hompland, MD, PhD · Oslo University Hospital

• Kjetil Boye, MD, PhD · Oslo University Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-26

Primary Completion

2029-01-26

Completion

2035-11-01

Countries

• Norway

Study Locations