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van der Kaaij RT, Braam HJ, Boot H, et al. Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR Res Protoc. 2017;6(7):e136doi: 10.2196/resprot.7790.
van der Kaaij, R. T., Braam, H. J., Boot, H., Los, M., Cats, A., Grootscholten, C., Schellens, J. H., Aalbers, A. G., Huitema, A. D., Knibbe, C. A., Boerma, D., Wiezer, M. J., van Ramshorst, B., & van Sandick, J. W. (2017). Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR research protocols, 6(7), e136. https://doi.org/10.2196/resprot.7790
van der Kaaij, Rosa T, et al. "Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study." JMIR research protocols vol. 6,7 (2017): e136. doi: https://doi.org/10.2196/resprot.7790
van der Kaaij RT, Braam HJ, Boot H, Los M, Cats A, Grootscholten C, Schellens JH, Aalbers AG, Huitema AD, Knibbe CA, Boerma D, Wiezer MJ, van Ramshorst B, van Sandick JW. Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study. JMIR Res Protoc. 2017 Jul 13;6(7):e136. doi: 10.2196/resprot.7790. PMID: 28705789; PMCID: PMC5532515.
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JMIR Res Protoc. 2017 Jul 13;6(7):e136. doi: 10.2196/resprot.7790.

Treatment of Peritoneal Dissemination in Stomach Cancer Patients With Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): Rationale and Design of the PERISCOPE Study.

JMIR research protocols

Rosa T van der Kaaij, Hidde Jw Braam, Henk Boot, Maartje Los, Annemieke Cats, Cecile Grootscholten, Jan Hm Schellens, Arend Gj Aalbers, Alwin Dr Huitema, Catherijne Aj Knibbe, Djamila Boerma, Marinus J Wiezer, Bert van Ramshorst, Johanna W van Sandick

Affiliations

  1. The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Department of Surgical Oncology, Amsterdam, Netherlands.
  2. St. Antonius Hospital, Department of Surgery, Nieuwegein, Netherlands.
  3. The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Department of Gastroenterology, Amsterdam, Netherlands.
  4. St. Antonius Hospital, Department of Medical Oncology, Nieuwegein, Netherlands.
  5. The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Department of Medical Oncology, Amsterdam, Netherlands.
  6. The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Department of Clinical Pharmacology, Amsterdam, Netherlands.
  7. The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Department of Pharmacy and Pharmacology, Amsterdam, Netherlands.
  8. University Medical Center Utrecht, Department of Clinical Pharmacy, Utrecht, Netherlands.
  9. St. Antonius Hospital, Department of Pharmacology, Nieuwegein, Netherlands.

PMID: 28705789 PMCID: PMC5532515 DOI: 10.2196/resprot.7790

Abstract

BACKGROUND: Patients with gastric cancer and peritoneal carcinomatosis have a very poor prognosis; median survival is 3 to 4 months. Palliative systemic chemotherapy is currently the only treatment available in the Netherlands. Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) has an established role in the treatment of peritoneal carcinomatosis originating from colorectal cancer, appendiceal cancer, and pseudomyxoma peritonei; its role in gastric cancer is uncertain. Currently, there is no consensus on the choice of chemotherapeutic agents used in HIPEC for gastric cancer.

OBJECTIVE: The main objectives of this study are (1) to investigate the safety, tolerability, and feasibility of gastrectomy combined with cytoreductive surgery and HIPEC after systemic chemotherapy, as a primary treatment option for patients with advanced gastric cancer with tumor positive peritoneal cytology and/or limited peritoneal carcinomatosis; and (2) to determine the maximum tolerated dose (MTD) of intraperitoneal docetaxel in combination with a fixed dose of intraperitoneal oxaliplatin.

METHODS: The PERISCOPE study is a multicenter, open label, phase I-II dose-escalation study. The MTD of docetaxel will be studied using a 3+3 design. Patients with locally advanced (cT3-cT4) gastric adenocarcinoma are eligible for inclusion if the primary gastric tumor is considered resectable, tumor positive peritoneal cytology and/or limited peritoneal carcinomatosis is confirmed by diagnostic laparoscopy/ laparotomy, and prior systemic chemotherapy was without disease progression. At laparotomy, cytoreductive surgery (complete removal of all macroscopically visible tumor deposits) and a total or partial gastrectomy with a D2 lymph node dissection is performed. An open HIPEC technique is used with 460mg/m2 hyperthermic oxaliplatin for 30 minutes (41°C to 42°C) followed by normothermic docetaxel for 90 minutes (37°C) in a dose that will be escalated per 3 patients (0, 50, 75, 100, 125, 150 mg/m2). The primary endpoint is treatment related toxicity.

RESULTS: Patient accrual is ongoing and the first results are expected in 2017.

CONCLUSIONS: The PERISCOPE study will determine the safety, tolerability, and feasibility of gastrectomy combined with cytoreduction and HIPEC using oxaliplatin in combination with docetaxel after systemic chemotherapy as primary treatment option for gastric cancer patients with tumor positive peritoneal cytology and/or limited peritoneal carcinomatosis. This study will provide pharmacokinetic data on the intraperitoneal administration of oxaliplatin and docetaxel, including the MTD of intraperitoneal-administered docetaxel. These data are a prerequisite for the safe conduct of future HIPEC studies in patients with gastric cancer.

TRIAL REGISTRATION: Netherlands Trial Registration (NTR): NTR4250; http://www.trialregister.nl/trialreg/admin/ rctview.asp?TC=4250 (Archived by WebCite at http://www.webcitation.org/6rWJONgkt).

©Rosa T van der Kaaij, Hidde JW Braam, Henk Boot, Maartje Los, Annemieke Cats, Cecile Grootscholten, Jan HM Schellens, Arend GJ Aalbers, Alwin DR Huitema, Catherijne AJ Knibbe, Djamila Boerma, Marinus J Wiezer, Bert van Ramshorst, Johanna W van Sandick. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.07.2017.

Keywords: HIPEC; cytoreduction; docetaxel; gastrectomy; gastric cancer; hyperthermic intraperitoneal chemotherapy; oxaliplatin; peritoneal carcinomatosis

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