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

  • STATUS
    Recruiting
  • End date
    May 9, 2024
  • participants needed
    64
  • sponsor
    University Hospital Heidelberg
Updated on 1 July 2021
soft tissue sarcoma

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.

Description

With retroperitoneal sarcomas, the patient benefits from neoadjuvant radiotherapy. Due to the special physical properties of particles (protons and C12 carbon ions), in particular the steep lateral dose drop, an improved protection of adjacent risk organs is e.g. Intestine, kidneys, liver etc. during the process of applying radiotherapy is possible.

The primary study objective is to demonstrate the safety and conduct of study treatment and the incidence of Grade 3-5 NCI-CTC-AE toxicity and / or termination of preferred therapy for any reason. Further target parameter is the proportion of applied therapies without the occurance of degree 3-5 NCI-CTC-AE(s).

The patients are randomized 1: 1 into the two arms (carbon ions vs. protons). Patients receive 39 Gy in (SD 3.0 Gy) in 6 fractions per week.

Secondary study objectives are local control (LC), local progression-free survival from the start of therapy (LPFS), disease-free survival (DFS), overall survival (OS) and quality of life (QoL) determined according to the EORTC-Quality of Life Questionaire (QLQ)- C30 questionnaire.

Details
Condition Sarcoma (Pediatric), Soft Tissue Sarcoma, Sarcoma
Treatment Proton Radiation, Carbon Ion radiation
Clinical Study IdentifierNCT04219202
SponsorUniversity Hospital Heidelberg
Last Modified on1 July 2021

Eligibility

Yes No Not Sure

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
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