ISAC: Ion Irradiation of Sacrococcygeal Chordoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: protons 16x4GyE protons |
Radiation: protons
Treatment is performed using 16 x 4 GyE protons
|
| Experimental: Carbon ions 16x4GyE carbon ions |
Radiation: carbon ions
Treatment is performed using 16 x 4 GyE carbon ions
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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)
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Heidelberg, Radiooncology, HIT | Heidelberg | Germany | 69125 |
Sponsors and Collaborators
- Heidelberg University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- ISAC-01