Actively Recruiting
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
Led by University Hospital Heidelberg · Updated on 2026-03-10
64
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and / or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.
CONDITIONS
Official Title
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable
- Karnofsky index of 1 70%
- Age 18 years or older
- Completed patient information and written consent
- Ability to give consent
You will not qualify if you...
- Stage IV disease with distant metastases
- Presence of lymphogenic metastasis
- Metal implants at the sarcoma site affecting treatment planning
- Previous radiation therapy in the treatment area
- Diagnosis of desmoid tumors, peritoneal sarcomatosis, or GIST
- Participation in another clinical study that might influence results
- Active medical implants without approval for ion irradiation (e.g., pacemaker, defibrillator)
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120
Actively Recruiting
Research Team
J
Juergen Debus, Prof.
CONTACT
K
Katharina Kozyra, 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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