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

ConditionsSoft Tissue Sarcoma (STS)Soft Tissue Sarcoma AdultSoft Tissue Sarcoma of the Trunk and ExtremitiesSynovial SarcomasUndifferentiated Pleomorphic Sarcoma (UPS)MyxofibrosarcomaLeiomyosarcoma (LMS)Pleomorphic LiposarcomaPleomorphic RhabdomyosarcomaLiposarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age at the time of informed consent.

Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).

Measurable disease according to RECIST v1.1.

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Disqualifiers

Patients with a 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 tumor site.

Patients with pacemakers and/or implanted defibrillators.

Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.

Trial design

Design model

Single group

Treatments tested in this trial

  • Definitive radiotherapy

    Radiation

    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).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Inoperable soft tissue sarcomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local progression-free survival

Local progression-free survival is measured from the date of start of study treatment until date of local progression of the tumor that has undergone proton beam radiotherapy evaluated using RECIST v1.1 or date of death of any cause, whichever occurs first.

Time frame
2 Year

Secondary outcomes

1

Progression-free survival

Progression-free survival is measured from the date of start of study treatment until date of progressive disease (local and/or distant) 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
2

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.
3

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.
4

Health-related quality of life

Change from baseline in EORTC QLQ-C30 scores.

Time frame
Up to five years after radiation therapy.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oslo University Hospital

Lead sponsor

Haukeland University Hospital

Collaborator

St. Olavs Hospital

Collaborator

University Hospital of North Norway

Collaborator

Source ClinicalTrials.gov
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