Actively Recruiting
Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions
Led by University Hospital Heidelberg · Updated on 2026-04-06
42
Participants Needed
1
Research Sites
418 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized prospective open-label phase 2 trial testes the safety and feasibility of a hypofractionated accelerated neoadjuvant proton or carbon ion radiotherapy based on the rate of wound healing disorders from beginning of radiotherapy to maximum 120 days after the planned tumor resection or discontinuation of treatment due to any reason. The treatment is of shorter duration (2-3 weeks vs. 5 weeks standard treatment), which should please most patients and thus enhance quality of life. The treatment regimen furthermore promises a reduced rate of late side effects and significant optimization of the current treatment standards. A phase II trial is mandatory not only for obtaining the safety and feasibility data, but also in order to prepare a concurrent phase III trial. Due to the low incidence of soft tissue sarcoma, only a well prepared multicenter study has a chance to be successfully completed based on previous experiences in trials for seldom tumor entities.
CONDITIONS
Official Title
Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed soft-tissue sarcoma of the extremities with need for perioperative radiation
- Tumor is resectable or marginally resectable
- Karnofsky performance score of 70% or higher
- Age 18 years or older
- Completed patient education and provided written consent
- Able to give informed consent
You will not qualify if you...
- Stage IV disease with distant metastases
- Presence of lymph node metastasis
- Metal implants affecting ion treatment planning
- Prior radiotherapy in the treatment area
- Diagnosis of desmoid tumors
- Participation in another clinical trial affecting study results
- Active medical implants not compatible with ion beam irradiation (e.g., pacemaker, defibrillator)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Heidelberg, Department of RadioOncology
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
Research Team
K
Klaus Herfarth, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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