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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Proton radiation
  • Carbon Ion radiation

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators