TY - JOUR
T1 - Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases
T2 - protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)
AU - Rovers, Koen P.
AU - Lurvink, Robin J.
AU - Wassenaar, Emma C. E.
AU - Kootstra, Thomas J. M.
AU - Scholten, Harm J.
AU - Tajzai, Rudaba
AU - Deenen, Maarten J.
AU - Nederend, Joost
AU - Lahaye, Max J.
AU - Huysentruyt, Clement J. R.
AU - van't Erve, Iris
AU - Fijneman, Remond J. A.
AU - Constantinides, Alexander
AU - Kranenburg, Onno
AU - Los, Maartje
AU - Thijs, Anna M. J.
AU - Creemers, Geert-Jan M.
AU - Burger, Jacobus W. A.
AU - Wiezer, Marinus J.
AU - Boerma, Djamila
AU - Nienhuijs, Simon W.
AU - de Hingh, Ignace H. J. T.
PY - 2019/8
Y1 - 2019/8
N2 - 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/m(2) body surface area (BSA)) with intravenous leucovorin (20 mg/m(2) BSA) and bolus 5-fluorouracil (400 mg/m(2) 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.
AB - 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/m(2) body surface area (BSA)) with intravenous leucovorin (20 mg/m(2) BSA) and bolus 5-fluorouracil (400 mg/m(2) 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.
KW - QUALITY-OF-LIFE
KW - INTRAABDOMINAL PRESSURE
KW - 1ST EVIDENCE
KW - CANCER
KW - PHARMACOKINETICS
KW - CARCINOMATOSIS
KW - SAFETY
KW - CLASSIFICATION
KW - QUESTIONNAIRE
KW - PENETRATION
U2 - 10.1136/bmjopen-2019-030408
DO - 10.1136/bmjopen-2019-030408
M3 - Article
C2 - 31352425
VL - 9
SP - 1
EP - 10
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 7
M1 - 030408
ER -