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
University Hospital Heidelberg
64 participants
May 9, 2019
INTERVENTIONAL
Conditions
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 Criteria5
- 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 Criteria8
- 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
Interventions
Therapeutic radiation Treatment with Protons
Therapeutic radiation Treatment with Carbon Ions
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04219202