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

NCT04219202 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Heidelberg

Phase

Not applicable

Started

2019-05-09

Last updated

2026-03-10

Condition(s) studied

Sarcoma,Soft Tissue

Investigational drug(s) / intervention(s)

Proton radiationCarbon Ion radiation

Proton radiation: Therapeutic radiation Treatment with Protons

Carbon Ion radiation: Therapeutic radiation Treatment with Carbon Ions

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
University Hospital of Heidelberg, Radiation Oncology	Heidelberg	Germany	Recruiting

More University Hospital Heidelberg trials in Germany

Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients Recruiting

Clinical Performance of Long-span Fixed Partial Dentures Recruiting

Magnetic Resonance Guided Adaptive Stereotactic Body Radiotherapy for Lung Tumors in Ultracentral Location Active, not recruiting

Tumor-specific T Cells in Lung Cancer Active, not recruiting

Cyclosporine In Takotsubo Syndrome Recruiting

Other trials for the same condition

GISAR German Interdisciplinary Sarcoma Registry Recruiting

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) Recruiting

The Epithelioid Hemangioendothelioma Registry of the European Reference Network on Rare Adult Solid Cancers (EURACAN) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04219202 on ClinicalTrials.gov ↗ ← All trials in Germany