Sacral Chordoma
Conditions
Keywords
sacral chordoma, chordoma, carbon ion therapy, proton therapy, hypofractionation
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 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.
Interventions
RADIATIONprotons
Treatment is performed using 16 x 4 GyE protons
RADIATIONcarbon ions
Treatment is performed using 16 x 4 GyE carbon ions
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local progression free survival (LPFS) | 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) | 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) | 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. |
Countries
Germany
Outcome results
None listed