Neoadjuvant radiation therapy for retroperitoneal soft tissue sarcoma using protons or carbon ions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and feasibility of a hypofractionated, accelerated radiation approach for patients with retroperitoneal soft tissue sarcomas. Participants will be randomly assigned to receive either proton or carbon ion radiation therapy before surgical resection of their tumors. The primary focus is on monitoring the incidence of severe adverse effects and the overall safety of the treatment. Secondary objectives include assessing local control, progression-free survival, disease-free survival, overall survival, and quality of life post-treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital of Heidelberg, Radiation Oncology
  Heidelberg, Germany Recruiting

Study contacts

• Study coordinator: Juergen Debus, Prof.
• Email: juergen.debus@med.uni-heidelberg.de
• Phone: +496221

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.