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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| protons | Experimental | 16x4GyE protons |
|
| Carbon ions | Experimental | 16x4GyE carbon ions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protons | Radiation | Treatment is performed using 16 x 4 GyE protons |
| |
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg, Radiooncology, HIT | Heidelberg | 69125 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24774721 | Background | Uhl M, Edler L, Jensen AD, Habl G, Oelmann J, Roder F, Jackel O, Debus J, Herfarth K. Randomized phase II trial of hypofractionated proton versus carbon ion radiation therapy in patients with sacrococcygeal chordoma-the ISAC trial protocol. Radiat Oncol. 2014 Apr 29;9:100. doi: 10.1186/1748-717X-9-100. |
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| ID | Term |
|---|---|
| D002817 | Chordoma |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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| carbon ions |
| Radiation |
Treatment is performed using 16 x 4 GyE carbon ions |
|
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. |
| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |