Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.
Recruiting
Phase 2
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Oslo University Hospital · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. ≥ 18 years of age at the time of informed consent.
2. Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).
3. Measurable disease according to RECIST v1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
5.…
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