Pre-surgery ion radiation for retroperitoneal soft tissue sarcoma
Tests proton or carbon ion radiation before surgery in adults with abdominal soft tissue sarcoma.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
Key facts
- Where
- Heidelberg, GermanySee the site
Where in Germany
- University Hospital of Heidelberg, Radiation OncologyHeidelberg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Heidelberg
- Trial code
- NCT04219202
- Record updated
- 10 March 2026
- Original description
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.Read full original descriptionShow less
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
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.
Inclusion: Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable; Karnofsky index of ≥ 70%; Age from 18 years; Completed patient information and written consent; ability to give consent.
Exclusion: Metal implants at the level of the sarcoma, which influence the treatment planning; Previous radiation therapy in the treatment area; Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator); Stage IV (distant metastases); Lymphogenic metastasis; Desmoid tumors, peritoneal sarcomatosis, GIST; Simultaneous participation in another clinical study that could influence the results of the respective study; Pregnant women.