NCT04219202Recruiting
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 3 Jan 2020
- Start date
- May 2019
- Primary completion date
- May 2026
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Sarcoma
- NCT number
- NCT04219202
What you commit to
- Study type: Interventional
- Planned participants: 64
- From May 2019 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Heidelberg, Radiation Oncology Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.