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Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study

BACKGROUND: Chordomas of the skull base are relative rare lesions of the bones. Surgical resection is the primary treatment standard, though complete resection is nearly impossible due to close proximity to critical and hence also dose limiting organs for radiation therapy. Level of recurrence after...

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Autores principales: Nikoghosyan, Anna V, Karapanagiotou-Schenkel, Irini, Münter, Marc W, Jensen, Alexandra D, Combs, Stephanie E, Debus, Jürgen
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2988755/
https://www.ncbi.nlm.nih.gov/pubmed/21054824
http://dx.doi.org/10.1186/1471-2407-10-607
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author Nikoghosyan, Anna V
Karapanagiotou-Schenkel, Irini
Münter, Marc W
Jensen, Alexandra D
Combs, Stephanie E
Debus, Jürgen
author_facet Nikoghosyan, Anna V
Karapanagiotou-Schenkel, Irini
Münter, Marc W
Jensen, Alexandra D
Combs, Stephanie E
Debus, Jürgen
author_sort Nikoghosyan, Anna V
collection PubMed
description BACKGROUND: Chordomas of the skull base are relative rare lesions of the bones. Surgical resection is the primary treatment standard, though complete resection is nearly impossible due to close proximity to critical and hence also dose limiting organs for radiation therapy. Level of recurrence after surgery alone is comparatively high, so adjuvant radiation therapy is very important for the improvement of local control rates. Proton therapy is the gold standard in the treatment of skull base chordomas. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. METHODS/DESIGN: This clinical study is a prospective randomised phase III trial. The trial will be carried out at Heidelberger Ionenstrahl-Therapie centre (HIT) and is a monocentric study. Patients with skull base chordoma will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume delineation will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment (accelerated dose) will be 63 Gy E ± 5% and 72 Gy E ± 5% (standard dose) in proton therapy respectively. Local-progression free survival (LPFS) will be analysed as primary end point. Toxicity and overall survival are the secondary end points. Additional examined parameters are patterns of recurrence, prognostic factors and plan quality analysis. DISCUSSION: Up until now it was impossible to compare two different particle therapies, i.e. protons and carbon ions directly at the same facility. The aim of this study is to find out, whether the biological advantages of carbon ion therapy can also be clinically confirmed and translated into the better local control rates in the treatment of skull base chordomas. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01182779
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spelling pubmed-29887552010-11-20 Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study Nikoghosyan, Anna V Karapanagiotou-Schenkel, Irini Münter, Marc W Jensen, Alexandra D Combs, Stephanie E Debus, Jürgen BMC Cancer Study Protocol BACKGROUND: Chordomas of the skull base are relative rare lesions of the bones. Surgical resection is the primary treatment standard, though complete resection is nearly impossible due to close proximity to critical and hence also dose limiting organs for radiation therapy. Level of recurrence after surgery alone is comparatively high, so adjuvant radiation therapy is very important for the improvement of local control rates. Proton therapy is the gold standard in the treatment of skull base chordomas. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. METHODS/DESIGN: This clinical study is a prospective randomised phase III trial. The trial will be carried out at Heidelberger Ionenstrahl-Therapie centre (HIT) and is a monocentric study. Patients with skull base chordoma will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume delineation will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment (accelerated dose) will be 63 Gy E ± 5% and 72 Gy E ± 5% (standard dose) in proton therapy respectively. Local-progression free survival (LPFS) will be analysed as primary end point. Toxicity and overall survival are the secondary end points. Additional examined parameters are patterns of recurrence, prognostic factors and plan quality analysis. DISCUSSION: Up until now it was impossible to compare two different particle therapies, i.e. protons and carbon ions directly at the same facility. The aim of this study is to find out, whether the biological advantages of carbon ion therapy can also be clinically confirmed and translated into the better local control rates in the treatment of skull base chordomas. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01182779 BioMed Central 2010-11-05 /pmc/articles/PMC2988755/ /pubmed/21054824 http://dx.doi.org/10.1186/1471-2407-10-607 Text en Copyright ©2010 Nikoghosyan et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Nikoghosyan, Anna V
Karapanagiotou-Schenkel, Irini
Münter, Marc W
Jensen, Alexandra D
Combs, Stephanie E
Debus, Jürgen
Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study
title Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study
title_full Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study
title_fullStr Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study
title_full_unstemmed Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study
title_short Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study
title_sort randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase iii study hit-1-study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2988755/
https://www.ncbi.nlm.nih.gov/pubmed/21054824
http://dx.doi.org/10.1186/1471-2407-10-607
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