Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial
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Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial Ping Jiang1,2†, Katja Krockenberger3†, Reinhard Vonthein3,4, Jane Tereszczuk3, Arne Schreiber3, Sebastian Liebau3, Stefan Huttenlocher5, Detlef Imhoff6, Panagiotis Balermpas5,6, Christian Keller5,6, Kathrin Dellas1, Rene Baumann1, Claus Rödel6, Guido Hildebrandt7, Klaus-Peter Jünemann8, Alex S. Merseburger9, Alan Katz10,11, Andreas Ziegler3,4,12, Oliver Blanck1,5 and Jürgen Dunst1,12,13,14*
Abstract Background: For prostate cancer treatment, treatment options with minimal side effects are desired. External beam radiation therapy (EBRT) is non-invasive, standard of care and delivered in either conventional fractionation over 8 weeks or with moderate hypo-fractionation over about 5 weeks. Recent advances in radiotherapy technology have made extreme hypo-fractionated stereotactic body radiation therapy (SBRT) of prostate cancer feasible, which has not yet been introduced as a standard treatment method in Germany. Initial results from other countries are promising, but long-term results are not yet available. The aim of this study is to investigate feasibility and effectiveness of SBRT for prostate cancer in Germany. Methods/design: This German bi-center single group trial (HYPOSTAT) is designed to evaluate feasibility and effectiveness, as measured by toxicity and PSA-response, respectively, of an extreme hypo-fractionated SBRT regimen with five fractions of 7 Gy in treatment of localized low and intermediate risk prostate cancer. The target volume includes the prostate with or without the base of seminal vesicles depending on risk stratification and uncertainty margins that are kept at 3–5 mm. SBRT treatment is delivered with the robotic CyberKnife system, which was recently introduced in Germany. Acute and late toxicity after one year will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE v. 4.0), Radiation Therapy Oncology Group (RTOG) and International Prostate Symptom Score (IPSS) Scores. The quality of life will be assessed before and after treatment with the EORTC QLQ C30 questionnaire. Hypothesizing that the proportion of patients with grade 2 side effects or higher is less or equal than 2.8%, thus markedly lower than the standard EBRT percentage (17.5%), the recruitment target is 85 patients. (Continued on next page)
* Correspondence: [email protected] † Equal contributors 1 Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Kiel, Germany 12 School of Mathematics, Statistics and Computer Science, University of KwaZulu-Natal, Pietermaritzburg, South Africa Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate
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