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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

RADIATION

Proton radiation

Therapeutic radiation Treatment with Protons

RADIATION

Carbon Ion radiation

Therapeutic radiation Treatment with Carbon Ions

Locations (1)

University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany