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

Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma,Soft Tissue
• Intervention / Treatment: Radiation: Proton radiation; Radiation: Carbon Ion radiation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juergen Debus, Prof.; Phone Number: 8201 +496221; Email: juergen.debus@med.uni-heidelberg.de
• Study Contact Backup: Name: Katharina Kozyra, Dr; Phone Number: 8201 +496221; Email: katharina.kozyra@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University Hospital of Heidelberg, Radiation Oncology
    • Contact: Matthias Uhl, PD; Phone Number: 8202 +49-6221-56; Email: Matthias.uhl@med.uni-heidelberg.de
    • Sub-Investigator: Katharina Seidensaal, MD
    • Contact: Adriane Hommertgen; Phone Number: 8202 +49-6221-56; Email: adriane.hommertgen@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proton Treatment; Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment	Radiation: Proton radiation; Therapeutic radiation Treatment with Protons
Experimental: Carbon Ion Treatment; Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment	Radiation: Carbon Ion radiation; Therapeutic radiation Treatment with Carbon Ions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of grad 3-5 NCI-CTC-AE toxicities	Evidence of the safety and practicability of the study treatment assessed for the incidence of grade 3-5 NCI-CTC-AE toxicity and / or termination of the planned therapy for any reason	within 12 month after radiation treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local Tumor control	Number of patients without new arising Tumors at the treated Tumor site	within 12 month after radiation treatment
local Progression free survival	Number of patients without local Progression at the treated tumor site	within 12 month after radiation treatment
disease free survival	Number of Patients without relapse of treated disease	within 12 month after radiation treatment
Overall survival	Assesment of alive patients	within 12 month after radiation treatment
Quality of live	Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6	within 12 month after radiation treatment

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Publications and helpful links

General Publications

• Seidensaal K, Kieser M, Hommertgen A, Jaekel C, Harrabi SB, Herfarth K, Mechtesheimer G, Lehner B, Schneider M, Nienhueser H, Frohling S, Egerer G, Debus J, Uhl M. Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial. Trials. 2021 Feb 12;22(1):134. doi: 10.1186/s13063-021-05069-z.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): May 9, 2027

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Therapeutics; Radiotherapy; Proton Therapy; Heavy Ion Radiotherapy
• Other Study ID Numbers: Rad-ONK Retro-Ion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No