RecruitingNot Applicable

Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion

Germany64 participantsStarted 2019-05-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of grad 3-5 NCI-CTC-AE toxicities

Timeframe: within 12 month after radiation treatment

Trial details

NCT IDNCT04219202

SponsorUniversity Hospital Heidelberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-09

Contact for this trial

Juergen Debus, Prof.

+496221 juergen.debus@med.uni-heidelberg.de