Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy versus palliative systemic chemotherapy in stomach cancer patients with peritoneal dissemination, the study protocol of a multicentre randomised controlled trial (PERISCOPE II)

W J Koemans, R T van der Kaaij, H Boot, T Buffart, A A F A Veenhof, K J Hartemink, C Grootscholten, P Snaebjornsson, V P Retel, H van Tinteren, S Vanhoutvin, V van der Noort, A Houwink, C Hahn, A D R Huitema, M Lahaye, M Los, P van den Barselaar, O Imhof, A Aalbers, G M van Dam, B van Etten, B P L Wijnhoven, M D P Luyer, D Boerma, J W van Sandick, W J Koemans, R T van der Kaaij, H Boot, T Buffart, A A F A Veenhof, K J Hartemink, C Grootscholten, P Snaebjornsson, V P Retel, H van Tinteren, S Vanhoutvin, V van der Noort, A Houwink, C Hahn, A D R Huitema, M Lahaye, M Los, P van den Barselaar, O Imhof, A Aalbers, G M van Dam, B van Etten, B P L Wijnhoven, M D P Luyer, D Boerma, J W van Sandick

Abstract

Background: At present, palliative systemic chemotherapy is the standard treatment in the Netherlands for gastric cancer patients with peritoneal dissemination. In contrast to lymphatic and haematogenous dissemination, peritoneal dissemination may be regarded as locoregional spread of disease. Administering cytotoxic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations can be delivered directly into the peritoneal cavity with limited systemic toxicity. The combination of a radical gastrectomy with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has shown promising results in patients with gastric cancer in Asia. However, the results obtained in Asian patients cannot be extrapolated to Western patients. The aim of this study is to compare the overall survival between patients with gastric cancer with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with palliative systemic chemotherapy, and those treated with gastrectomy, CRS and HIPEC after neoadjuvant systemic chemotherapy.

Methods: In this multicentre randomised controlled two-armed phase III trial, 106 patients will be randomised (1:1) between palliative systemic chemotherapy only (standard treatment) and gastrectomy, CRS and HIPEC (experimental treatment) after 3-4 cycles of systemic chemotherapy.Patients with gastric cancer are eligible for inclusion if (1) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable, (2) limited peritoneal dissemination (Peritoneal Cancer Index < 7) and/or tumour positive peritoneal cytology are confirmed by laparoscopy or laparotomy, and (3) systemic chemotherapy was given (prior to inclusion) without disease progression.

Discussion: The PERISCOPE II study will determine whether gastric cancer patients with limited peritoneal dissemination and/or tumour positive peritoneal cytology treated with systemic chemotherapy, gastrectomy, CRS and HIPEC have a survival benefit over patients treated with palliative systemic chemotherapy only.

Trial registration: clinicaltrials.gov NCT03348150 ; registration date November 2017; first enrolment November 2017; expected end date December 2022; trial status: Ongoing.

Keywords: Cytoreductive surgery; Gastrectomy; Gastric cancer; HIPEC; Hyperthermic intraperitoneal chemotherapy; Palliative systemic chemotherapy; Peritoneal metastasis; Peritonitis carcinomatosa; Surgery.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol has been approved by the medical ethical committee of the Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital. All patients signed informed consent before study enrolment. The study is performed in accordance with the declaration of Helsinki. The protocol of this study is registered at the Netherlands Trial Registration under identification number NL56123.031.15 and at www.clinicaltrials.gov under identification number NCT03348150.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
PERISCOPE II study flowchart. HIPEC: Hyperthermic Intraperitoneal Chemotherapy
Fig. 2
Fig. 2
Peritoneal cancer index [18]

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