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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01811394
Study type Interventional
Source Heidelberg University
Contact
Status Active, not recruiting
Phase Phase 2
Start date January 2013
Completion date June 2025