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Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.

NCT07173972 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-28

No results posted yet for this study

Summary

The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects.

The planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction).

At the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans.

The primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life.

The study will be conducted in Norway, with a planned inclusion of 40 patients.

Conditions

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

Interventions

RADIATION

Definitive radiotherapy

The prescribed dose is 56 Gray (Gy) in 16 fractions over 4 weeks (14 Gy per week) with a maximum dose-escalation to the tumor core of 80 Gy (5 Gy per fraction).

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • University Hospital of North Norway

    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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173972 on ClinicalTrials.gov