Ion Irradiation of Sacrococcygeal Chordoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sacral Chordoma

Intervention / Treatment
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* Radiation: protons
* Radiation: carbon ions


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protons<br>16x4GyE protons | Radiation: protons<br>* Treatment is performed using 16 x 4 GyE protons<br>|
| Experimental: Carbon ions<br>16x4GyE carbon ions | Radiation: carbon ions<br>* Treatment is performed using 16 x 4 GyE carbon ions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique | 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 | From date of treatment start until 12 months after treatment. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacral chordoma, chordoma, carbon ion therapy, proton therapy, hypofractionation