Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma
18 Years
80 Years
Both
Exposure to Artificially Accelerated Beams of Ionized Particles Generated by Synchrotrons
Trial Information
Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma
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 approveal at the time of ion irradiation
(eg, cardiac pacemaker, defibrillator)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
safety and feasibility of hypofractionated irradiation in patients with sacrococygeal chordoma using ions (protons or carbon ions) in raster scan technique
Outcome Description:
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
Outcome Time Frame:
From date of treatment start until 12 months after treatment.
Authority:
Germany: Federal Office for Radiation Protection
Study ID:
ISAC-01
NCT ID:
NCT01811394
Start Date:
January 2013
Completion Date:
January 2016
Related Keywords:
- Exposure to Artificially Accelerated Beams of Ionized Particles Generated by Synchrotrons
- sacral chordoma
- chordoma
- carbon ion therapy
- proton therapy
- hypofractionation
- Chordoma
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