Journal Article

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)

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

2019

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Analysis / Antineoplastic Combined Chemotherapy Protocols - administration & dosage / Biomedical and Life Sciences / Biomedicine / cancer imaging / Cancer metastasis / Cancer patients / Cancer Research / Cancer therapies / Cancer treatment / Care and treatment / Cellular biology / Chemotherapy / Chemotherapy, Adjuvant - economics / Chemotherapy, Adjuvant - methods / Clinical trials / Clinical Trials, Phase III as Topic / Cost-Benefit Analysis / Cytology / Cytoreduction Surgical Procedures - economics / Cytoreduction Surgical Procedures - methods / Cytoreductive surgery / Cytotoxicity / Debulking / Disease-Free Survival / Female / Gastrectomy / Gastrectomy - economics / Gastrectomy - methods / Gastric cancer / Health aspects / Health insurance / Health Promotion and Disease Prevention / HIPEC / Humans / Hyperthermia, Induced - economics / Hyperthermia, Induced - methods / Hyperthermic intraperitoneal chemotherapy / interventional therapeutics / Kaplan-Meier Estimate / Laparoscopy / Laparotomy / Lymph nodes / Male / Medical prognosis / Medical research / Medicine/Public Health / Metastasis / Multicenter Studies as Topic / Netherlands - epidemiology / Oncology / Palliation / Palliative Care - economics / Palliative Care - methods / Patients / Peritoneal metastasis / Peritoneal Neoplasms - economics / Peritoneal Neoplasms - secondary / Peritoneal Neoplasms - therapy / Peritoneum / Peritoneum - pathology / Peritonitis / Peritonitis carcinomatosa / R&D / Randomized Controlled Trials as Topic / Research & development / Stomach cancer / Stomach Neoplasms - economics / Stomach Neoplasms - pathology / Stomach Neoplasms - therapy / Study Protocol / Surgery / Surgical Oncology / Survival / Systematic review / Toxicity / Tumors