Acronym

PIPAC-II

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

Lead investigator:

Dr. I.H.J.T. (Ignace) de Hingh
E: ignace.d.hingh@catharinaziekenhuis.nl

Other principal investigators:

Dr. D. (Djamila) Boerma

E: d.boerma@antoniusziekenhuis.nl

Coordinating investigator Catharina Hospital:

Drs. R. (Robin) Lurvink

Research Heelkunde, Postbus 1350, 5602 ZA, Eindhoven

E: robin.lurvink@catharinaziekenhuis.nl

T: +3140 239 6354

Coordinating investigator St. Antonius Hospital:

Drs. P. (Paulien) Rauwerdink

Research Heelkundem, Koekoekslaan 1, 3435 CM, Nieuwegein

E: p.rauwerdink@antoniusziekenhuis.nl

T: +3188 320 19 26

 

 

Summary study

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.

Secondary endpoints:

Quality of life, histocytological/radiological/biochemical/clinical response, progression free survival, overall survival, costs.

Intervention

Up to three cycles of bidirectional therapy, each cycle starting with six weeks of palliative systemic chemotherapy followed by one laparoscopic ePIPAC-OX.

Participating centers:

• Catharina Ziekenhuis, Eindhoven
• Antonius Ziekenhuis, Nieuwegein