Ion Irradiation of Sacrococcygeal Chordoma

  • STATUS
    Recruiting
  • End date
    Jun 5, 2025
  • participants needed
    100
  • sponsor
    Heidelberg University
Updated on 5 September 2021

Summary

The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the raster scan technique.

Description

The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection. The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity (CTCAE, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. Local-progression free survival, overall survival and quality of life will be analyzed as secondary end points.

Details
Condition Sacral Chordoma
Treatment protons, protons, carbon ions
Clinical Study IdentifierNCT01811394
SponsorHeidelberg University
Last Modified on5 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histological confirmation of sacrococcygeal chordoma
Karnofsky performance status 70%
Patients age 18 - 80 years
Macroscopic tumour (MRI)
Written informed consent

Exclusion Criteria

Lack of macroscopic tumour
Tumor extension in craniocaudal direction >16cm
Metal implants at the level of the tumor which could influence the treatment planning
Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)
Prior radiotherapy of the pelvic region
Simultaneous participation in another trial that could influence the results of the study
Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
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