Neoplasms

All Conditions

Rare Diseases

Chordoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Treatment is performed using 16 x 4 GyE protons

protons

Treatment is performed using 16 x 4 GyE carbon ions

carbon ions

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.

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.

Ion Irradiation of Sacrococcygeal Chordoma

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

The evaluation is based on incidence of Grade 3-5 toxicity (NCI-CTC-AE) and/or discontinuation of the treatment for any reason. Endpoint is the proportion of treatments without Grade 3-5 toxicity (NCI-CTC-AE) up to 12 months after treatment and/or discontinuation of the treatment for any reason

local progression free survival (LPFS) is determined from start of treatment until local progression in imaging (\>10% size increase)

Further objectives are overall survival (OS) from date of treatment start until the date of death from any cause assessed up to 12 months

Quality of life (QoL) evaluated with EORTC-QLQ30 questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ion Irradiation of Sacrococcygeal Chordoma	NCT01811394	Sacral Chordoma	protons carbon ions	18 Years - 80 Years	Heidelberg University
Ion Irradiation of Sacrococcygeal Chordoma	NCT01811394	Sacral Chordoma	protons carbon ions	18 Years - 80 Years	Heidelberg University

Spots Global Cancer Trial Database for sacral chordoma