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

Sarcoma,Soft Tissue Clinical Trial

— Retro-Ion  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04219202
• Other study ID #: Rad-ONK Retro-Ion
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: May 9, 2027

Study information

• Verified date: January 2024
• Source: University Hospital Heidelberg
• Contact: Juergen Debus, Prof.
• Phone: +496221
• Email: juergen.debus[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 9, 2027
• Est. primary completion date: May 9, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma,Soft Tissue

Intervention

Radiation:
• Proton radiation
Therapeutic radiation Treatment with Protons
• Carbon Ion radiation
Therapeutic radiation Treatment with Carbon Ions

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg, Radiation Oncology	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

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