Protocol of a retrospective, multicentre observational study on hyperthermic intrathoracic chemotherapy in Germany

Abstract

IntroductionObjective 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 analysisThis 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 disseminationThe 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 numberGerman Clinical Trials Registry (DRKS00015012; Pre-results).

Hyperthermic Intrathoracic Chemotherapy (HITOC) after Cytoreductive Surgery for Pleural Malignancies—A Retrospective, Multicentre Study

“…The approval of the ethics committee of the University of Regensburg (reference number: 18-1119-104) and of the ethics committees of the participating centres was obtained. The study protocol was developed and published before collecting and analyzing the data [ 14 ].…”

“…The study protocol specified the following inclusion criteria: malignant pleural tumours and HITOC after CRS in one surgery. Conversely, treatment without HITOC and HITOC without CRS (not following consensus-based recommendations) were exclusion criteria [ 14 ]. The choice of chemotherapeutic agents (alone or in combination) and also the dosage of chemotherapeutic agents for the intracavitary administration was determined by each hospital according to its own experience and protocols independently of clinical conditions.…”

“…There is no standardization for HITOC as a procedure or international guideline concerning the administration of chemotherapeutic agents, optimal duration of perfusion or optimal perioperative management of these patients. Therefore, CRS-HITOC is performed by adapting international reported experiences and individual protocols [ 14 ].…”

Hyperthermic intrathoracic chemotherapy (HITHOC): narrative review of the current literature, recommendations and future studies

“…Currently, a retrospective, multi-center observational study, which is funded by the German Research Foundation analyses approximately 350 patients who underwent surgical cytoreduction combined with subsequent HITHOC in four German University Hospitals (46). The results of this retrospective, multi-center study should allow a better standardization of the HITHOC-procedure including D with or without HITHOC.…”

Hyperthermic intrathoracic chemotherapy (HITHOC) should be included in the guidelines for malignant pleural mesothelioma

“…The HITHOC acts with a double action: chemotherapeutic drug has a local and direct effect on the tumor cells while hyperthermia enhances the impact of chemotherapy by increasing its penetration into the tissue (13). Furthermore, although many experiences and studies have been reported to date, there is no standardized protocol for HITHOC (14)(15)(16).…”