Name of the study
Bidirectional treatment consisting of repetitive laparoscopic electrostatic pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) and systemic intravenous chemotherapy for isolated unresectable colorectal peritoneal metastases: feasibility, safety, tolerability, and preliminary efficacy
Researchers and contact information
Dr. I.H.J.T. (Ignace) de Hingh
Other principal investigators:
Dr. D. (Djamila) Boerma
Coordinating investigator Catharina Hospital:
Drs. R. (Robin) Lurvink
Research Heelkunde, Postbus 1350, 5602 ZA, Eindhoven
T: +3140 239 6354
Coordinating investigator St. Antonius Hospital:
Drs. P. (Paulien) Rauwerdink
Research Heelkundem, Koekoekslaan 1, 3435 CM, Nieuwegein
T: +3188 320 19 26
Rationale: Bidirectional therapy, consisting of multiple cycles of systemic chemotherapy followed by electrostatic pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX), could be more effective against colorectal peritoneal metastases as compared to monotherapy with either systemic chemotherapy or ePIPAC-OX. However, there is no experience with bidirectional therapy in the Netherlands. Therefore, its safety and feasibility should be determined first.
Study design: This is a prospective, multicenter, single arm, phase II study.
Study population: Twenty adults (WHO 0-1) with histologically confirmed asymptomatic isolated unresectable PM from a colorectal or appendiceal carcinoma, without contraindications for laparoscopy or the planned chemotherapy, and without previous PIPAC-procedures.
Primary endpoint: Safety and feasibility.
- Safety: the number of patients with major toxicity, defined as a grade ≥3 according to the Common Terminology Criteria for Adverse Events v5.0, and measured up to four weeks after the last cycle of laparoscopic ePIPAC-OX and systemic chemotherapy.
- Feasibility: the number of patients able to undergo three cycles of bidirectional therapy.
Quality of life, histocytological/radiological/biochemical/clinical response, progression free survival, overall survival, costs.
Up to three cycles of bidirectional therapy, each cycle starting with six weeks of palliative systemic chemotherapy followed by one laparoscopic ePIPAC-OX.
- Catharina Ziekenhuis, Eindhoven
- Antonius Ziekenhuis, Nieuwegein