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Protocol
Protocol of a retrospective, multicentre observational study on hyperthermic intrathoracic chemotherapy in Germany
  1. Till Markowiak1,
  2. Michael Koller2,
  3. Florian Zeman2,
  4. Gunnar Huppertz2,
  5. Hans-Stefan Hofmann1,
  6. Michael Ried1
  7. HITOC Study Group
    1. 1Department of Thoracic Surgery, Universitätsklinikum Regensburg, Regensburg, Bayern, Germany
    2. 2Center for Clinical Studies, Universitätsklinikum Regensburg, Regensburg, Bayern, Germany
    1. Correspondence to Professor Michael Ried; michael.ried{at}ukr.de

    Abstract

    Introduction Objective of the ‘German hyperthermic intrathoracic chemotherapy (HITOC) study’ is to evaluate the HITOC as additional treatment after surgical cytoreduction for malignant pleural tumours. Even though HITOC is applied with increasing frequency, there is no standardised therapy protocol concerning the technique of HITOC, the selection as well as dosage of chemotherapeutic agents and perioperative management in order to provide a safe and comparable, standardised treatment regime.

    Methods and analysis This trial is a retrospective, multicentre observational study, which is funded by the German Research Foundation. Approximately 300 patients will be included. Four departments of thoracic surgery, which are performing the most HITOC procedures in Germany, are contributing to this study: Center for Thoracic Surgery at the University Hospital Regensburg, Thoracic Clinic Heidelberg of the University of Heidelberg, Center for Thoracic Surgery of the Hospital University of Munich and the Department of Thoracic Surgery at the University Hospital Freiburg. All patients who underwent surgical cytoreduction and subsequent HITOC at one of the four centres between starting the HITOC programme in 2008 and December 2019 will be included. Information on the performed HITOC will be obtained, focusing on the technique as well as the applied perfusion solution including the chemotherapeutic agent. Furthermore, parameters of the patient’s postoperative recovery will be analysed to determine 30-day morbidity and mortality.

    Ethics and dissemination The approvals by the local ethics committee of the respective clinic and the three participating clinics have been obtained. The results will be presented in conferences and published in a peer-reviewed journal.

    Trial registration number German Clinical Trials Registry (DRKS00015012; Pre-results).

    • thoracic surgery
    • thoracic medicine
    • adult oncology
    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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    Footnotes

    • Collaborators HITOC Study Group:Hauke Winter; Martin Eichhorn; Laura Klotz; Rudolf Hatz; Julia Zimmermann; Julia Kovacs; Bernward Passlick; Severin Schmid; Mohamed Hassan.

    • Contributors TM and MR wrote the manuscript. FZ, GH and MK proved the manuscript regarding the study design and the described statistical analysis. H-SH and all collaborators of the HITOC Study Group revised the manuscript critically. All authors approved the final version of the manuscript.

    • Funding This work was supported by the German Research Foundation, Kennedyallee 40, 53170, Bonn, Germany (Grant number GZ: RI 2905/3-1).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

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