NCT04219202 Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
| NCT ID | NCT04219202 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Sarcoma,Soft Tissue |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2019-05-09 |
| Primary Completion | 2026-05-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2019-05-09 with a primary completion date of 2026-05-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Stage IV (distant metastases) * Lymphogenic metastasis * Metal implants at the level of the sarcoma, which influence the treatment planning * Previous radiation therapy in the treatment area * Desmoid tumors, peritoneal sarcomatosis, GIST * Simultaneous participation in another clinical study that could influence the results of the respective study * Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator) * Pregnant women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04219202 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcoma,Soft Tissue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04219202 currently recruiting?
Yes, NCT04219202 is actively recruiting participants. Contact the research team at juergen.debus@med.uni-heidelberg.de for enrollment information.
Where is the NCT04219202 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT04219202 clinical trial?
NCT04219202 is sponsored by University Hospital Heidelberg. The trial plans to enroll 64 participants.