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

RecruitingNAAges 18 Years - anyAllUniversity Hospital Heidelberg
NCT04219202 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Proton radiation
  • Carbon Ion radiation
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Where

1 site
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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