Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04219202

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

Led by University Hospital Heidelberg · Updated on 2026-03-10

64

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable
  • Karnofsky index of 1 70%
  • Age 18 years or older
  • Completed patient information and written consent
  • Ability to give consent
Not Eligible

You will not qualify if you...

  • Stage IV disease with distant metastases
  • Presence of lymphogenic metastasis
  • Metal implants at the sarcoma site affecting treatment planning
  • Previous radiation therapy in the treatment area
  • Diagnosis of desmoid tumors, peritoneal sarcomatosis, or GIST
  • Participation in another clinical study that might influence results
  • Active medical implants without approval for ion irradiation (e.g., pacemaker, defibrillator)
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

J

Juergen Debus, Prof.

CONTACT

K

Katharina Kozyra, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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