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Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC).

Authors
  • Rovers, Koen P1
  • Lurvink, Robin J1
  • Wassenaar, Emma Ce2
  • Kootstra, Thomas Jm2
  • Scholten, Harm J3
  • Tajzai, Rudaba4
  • Deenen, Maarten J4
  • Nederend, Joost5
  • Lahaye, Max J6
  • Huysentruyt, Clément Jr7
  • van 't Erve, Iris8
  • Fijneman, Remond Ja8
  • Constantinides, Alexander9
  • Kranenburg, Onno9
  • Los, Maartje10
  • Thijs, Anna Mj11
  • Creemers, Geert-Jan M11
  • Burger, Jacobus Wa1
  • Wiezer, Marinus J2
  • Boerma, Djamila2
  • And 2 more
  • 1 Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands. , (Netherlands)
  • 2 Department of Surgery, Sint Antonius Hospital, Nieuwegein, The Netherlands. , (Netherlands)
  • 3 Department of Anaesthesiology, Catharina Hospital, Eindhoven, The Netherlands. , (Netherlands)
  • 4 Department of Clinical Pharmacy, Catharina Hospital, Eindhoven, The Netherlands. , (Netherlands)
  • 5 Department of Radiology, Catharina Hospital, Eindhoven, The Netherlands. , (Netherlands)
  • 6 Department of Radiology, Netherlands Cancer Institute, Amsterdam, The Netherlands. , (Netherlands)
  • 7 Department of Pathology, Catharina Hospital, Eindhoven, The Netherlands. , (Netherlands)
  • 8 Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands. , (Netherlands)
  • 9 Imaging and Cancer, UMC Utrecht, Utrecht, The Netherlands. , (Netherlands)
  • 10 Department of Medical Oncology, Sint Antonius Hospital, Nieuwegein, The Netherlands. , (Netherlands)
  • 11 Department of Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands. , (Netherlands)
  • 12 GROW - School for Oncology and Development Biology, Maastricht University, Maastricht, Netherlands. , (Netherlands)
Type
Published Article
Journal
BMJ Open
Publisher
BMJ
Publication Date
Jul 27, 2019
Volume
9
Issue
7
Identifiers
DOI: 10.1136/bmjopen-2019-030408
PMID: 31352425
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) is offered as a palliative treatment option for patients with isolated unresectable colorectal peritoneal metastases (PM) in several centres worldwide. However, little is known about its feasibility, safety, tolerability, efficacy, costs and pharmacokinetics in this setting. This study aims to explore these parameters in patients with isolated unresectable colorectal PM who receive repetitive ePIPAC-OX as a palliative monotherapy. This multicentre, open-label, single-arm, phase II study is performed in two Dutch tertiary referral hospitals for the surgical treatment of colorectal PM. Eligible patients are adults who have histologically or cytologically proven isolated unresectable PM of a colorectal or appendiceal carcinoma, a good performance status, adequate organ functions and no symptoms of gastrointestinal obstruction. Instead of standard palliative treatment, enrolled patients receive laparoscopy-controlled ePIPAC-OX (92 mg/m2 body surface area (BSA)) with intravenous leucovorin (20 mg/m2 BSA) and bolus 5-fluorouracil (400 mg/m2 BSA) every 6 weeks. Four weeks after each procedure, patients undergo clinical, radiological and biochemical evaluation. ePIPAC-OX is repeated until disease progression, after which standard palliative treatment is (re)considered. The primary outcome is the number of patients with major toxicity (grade ≥3 according to the Common Terminology Criteria for Adverse Events v4.0) up to 4 weeks after the last ePIPAC-OX. Secondary outcomes are the environmental safety of ePIPAC-OX, procedure-related characteristics, minor toxicity, postoperative complications, hospital stay, readmissions, quality of life, costs, pharmacokinetics of oxaliplatin, progression-free survival, overall survival, and the radiological, histopathological, cytological, biochemical and macroscopic tumour response. This study is approved by an ethics committee, the Dutch competent authority and the institutional review boards of both study centres. Results are intended for publication in peer-reviewed medical journals and for presentation to patients, healthcare professionals and other stakeholders. NCT03246321, Pre-results; ISRCTN89947480, Pre-results; NTR6603, Pre-results; EudraCT: 2017-000927-29, Pre-results. © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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