Ion Irradiation of Sacrococcygeal Chordoma
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
Inclusion Criteria
- Macroscopic tumour (MRI)
- Histological confirmation of sacrococcygeal chordoma
- Written informed consent
- ...
- Macroscopic tumour (MRI)
- Histological confirmation of sacrococcygeal chordoma
- Written informed consent
- Karnofsky performance status ≥ 70%
- Patients age 18 - 80 years
Exclusion Criteria
- Tumor extension in craniocaudal direction >16cm
- Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
- Metal implants at the level of the tumor which could influence the treatment planning
- ...
- Tumor extension in craniocaudal direction >16cm
- Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
- Metal implants at the level of the tumor which could influence the treatment planning
- Simultaneous participation in another trial that could influence the results of the study
- Lack of macroscopic tumour
- Prior radiotherapy of the pelvic region
- Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)
Summary
- Conditions
- Sacral Chordoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 tr...
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.
Inclusion Criteria
- Macroscopic tumour (MRI)
- Histological confirmation of sacrococcygeal chordoma
- Written informed consent
- ...
- Macroscopic tumour (MRI)
- Histological confirmation of sacrococcygeal chordoma
- Written informed consent
- Karnofsky performance status ≥ 70%
- Patients age 18 - 80 years
Exclusion Criteria
- Tumor extension in craniocaudal direction >16cm
- Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
- Metal implants at the level of the tumor which could influence the treatment planning
- ...
- Tumor extension in craniocaudal direction >16cm
- Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
- Metal implants at the level of the tumor which could influence the treatment planning
- Simultaneous participation in another trial that could influence the results of the study
- Lack of macroscopic tumour
- Prior radiotherapy of the pelvic region
- Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)
Tracking Information
- NCT #
- NCT01811394
- Collaborators
- Not Provided
- Investigators
- Not Provided
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