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

Not Applicable

Recruiting

• Conditions: Sarcoma,Soft Tissue
• Interventions: Radiation: Proton radiation; Radiation: Carbon Ion radiation

• Registration Number: NCT04219202
• Lead Sponsor: University Hospital Heidelberg

Brief 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.

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 Timeline

• Study Start: 2019-05-09
• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2026-05-09
• Study Completion: 2027-05-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proton Treatment	Proton radiation	Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment
Carbon Ion Treatment	Carbon Ion radiation	Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment

Primary Outcome Measures

Name	Time	Method
Incidence of grad 3-5 NCI-CTC-AE toxicities	within 12 month after radiation treatment	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Heidelberg, Radiation Oncology; 🇩🇪 Heidelberg, Germany