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

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

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

Conditions2

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