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)
Introduction 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 i...
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2019-07-01
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| author | Maarten J Deenen Koen P Rovers Robin J Lurvink Emma CE Wassenaar Thomas JM Kootstra Harm J Scholten Rudaba Tajzai Joost Nederend Max J Lahaye Clément JR Huysentruyt Iris van ’t Erve Remond JA Fijneman Alexander Constantinides Onno Kranenburg Maartje Los Anna MJ Thijs Geert-Jan M Creemers Jacobus WA Burger Marinus J Wiezer Djamila Boerma Simon W Nienhuijs Ignace HJT de Hingh |
| author_facet | Maarten J Deenen Koen P Rovers Robin J Lurvink Emma CE Wassenaar Thomas JM Kootstra Harm J Scholten Rudaba Tajzai Joost Nederend Max J Lahaye Clément JR Huysentruyt Iris van ’t Erve Remond JA Fijneman Alexander Constantinides Onno Kranenburg Maartje Los Anna MJ Thijs Geert-Jan M Creemers Jacobus WA Burger Marinus J Wiezer Djamila Boerma Simon W Nienhuijs Ignace HJT de Hingh |
| author_sort | Maarten J Deenen |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT03246321, Pre-results; ISRCTN89947480, Pre-results; NTR6603, Pre-results; EudraCT: 2017-000927-29, Pre-results. |
| format | Article |
| id | doaj-art-c7c7a260fb6341a386a5b94518c0ddbf |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-07-01 |
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| series | BMJ Open |
| spelling | doaj-art-c7c7a260fb6341a386a5b94518c0ddbf2024-11-23T03:30:08ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2019-030408Repetitive 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)Maarten J Deenen0Koen P Rovers1Robin J Lurvink2Emma CE Wassenaar3Thomas JM Kootstra4Harm J Scholten5Rudaba Tajzai6Joost Nederend7Max J Lahaye8Clément JR Huysentruyt9Iris van ’t Erve10Remond JA Fijneman11Alexander Constantinides12Onno Kranenburg13Maartje Los14Anna MJ Thijs15Geert-Jan M Creemers16Jacobus WA Burger17Marinus J Wiezer18Djamila Boerma19Simon W Nienhuijs20Ignace HJT de Hingh214 Department of Clinical Pharmacy, Catharina Hospital, Eindhoven, The Netherlands4 Department of Surgery, Catharina Cancer Institute, Eindhoven, The NetherlandsDepartment of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands2 Department of Surgery, Sint Antonius Hospital, Nieuwegein, The Netherlands2 Department of Surgery, Sint Antonius Hospital, Nieuwegein, The Netherlands3 Department of Anaesthesiology, Catharina Hospital, Eindhoven, The Netherlands4 Department of Clinical Pharmacy, Catharina Hospital, Eindhoven, The NetherlandsDepartment of Radiology, Catharina Hospital, Eindhoven, The Netherlands6 Department of Radiology, Netherlands Cancer Institute, Amsterdam, The Netherlands7 Department of Pathology, Catharina Hospital, Eindhoven, The Netherlands8 Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands8 Department of Pathology, Netherlands Cancer Institute, Amsterdam, The Netherlands9 Imaging and Cancer, UMC Utrecht, Utrecht, The NetherlandsDepartment of Surgical Oncology and Utrecht Platform for Organoid Technology, UMC Utrecht, Utrecht, The Netherlands10 Department of Medical Oncology, Sint Antonius Hospital, Nieuwegein, The Netherlands11 Department of Medical Oncology, Catharina Hospital, Eindhoven, The NetherlandsDepartment of Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands1 Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands2 Department of Surgery, Sint Antonius Hospital, Nieuwegein, The Netherlands2 Department of Surgery, Sint Antonius Hospital, Nieuwegein, The NetherlandsDepartment of Surgery, Catharina Hospital, Eindhoven, The Netherlands1 Department of Surgery, Catharina Hospital, Eindhoven, The NetherlandsIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT03246321, Pre-results; ISRCTN89947480, Pre-results; NTR6603, Pre-results; EudraCT: 2017-000927-29, Pre-results.https://bmjopen.bmj.com/content/9/7/e030408.full |
| spellingShingle | Maarten J Deenen Koen P Rovers Robin J Lurvink Emma CE Wassenaar Thomas JM Kootstra Harm J Scholten Rudaba Tajzai Joost Nederend Max J Lahaye Clément JR Huysentruyt Iris van ’t Erve Remond JA Fijneman Alexander Constantinides Onno Kranenburg Maartje Los Anna MJ Thijs Geert-Jan M Creemers Jacobus WA Burger Marinus J Wiezer Djamila Boerma Simon W Nienhuijs Ignace HJT de Hingh 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/7/e030408.full |
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