Clinical Trial: Ion Irradiation of Sacrococcygeal Chordoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Heidelberg University

Current Primary Outcome: safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique [ Time Frame: From date of treatment start until 12 months after treatment. ]

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


Original Primary Outcome: safety and feasibility of hypofractionated irradiation in patients with sacrococygeal chordoma using ions (protons or carbon ions) in raster scan technique [ Time Frame: From date of treatment start until 12 months after treatment. ]

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


Current Secondary Outcome:

  • local progression free survival (LPFS) [ Time Frame: From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months. ]
    local progression free survival (LPFS) is determined from start of treatment until local progression in imaging (>10% size increase)
  • Overall survival (OS) [ Time Frame: From date of treatment start until the date of death from any cause assessed up to 12 months. ]
    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) [ Time Frame: From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment. ]
    Quality of life (QoL) evaluated with EORTC-QLQ30 questionnaire.


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: March 9, 2013
Date Started: January 2013
Date Completion: June 2020
Last Updated: May 1, 2017
Last Verified: May 2017