NCT01811394

Ion Irradiation of Sacrococcygeal Chordoma

Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sacral Chordoma

Interventions

Type	Name	Description
RADIATION	protons	Treatment is performed using 16 x 4 GyE protons
RADIATION	carbon ions	Treatment is performed using 16 x 4 GyE carbon ions

Timeline

• Start date: 2013-01-01
• Primary completion: 2023-02-01
• Completion: 2025-06-01
• First posted: 2013-03-14
• Last updated: 2023-12-06

Locations

1 site across 1 country: Germany