PIPAC and Systemic Chemotherapy for Irresectable Colorectal Peritoneal Metastases. (CRC-PIPAC-II)

Interventions: Bidirectional therapy
Patients are treated with three rounds of bidirectional therapy. Each round of bidirectional therapy consists of 2 cycles of systemic chemotherapy with CAPOX-bevacizumab OR 3 cycles of systemic chemotherapy with FOLFOX-bevacizumab / FOLFIRI-bevacizumab / FOLFOXIRI-bevacizumab. After 2 or 3 cycles of systemic chemotherapy, patients receive 1 electrostatic PIPAC with oxaliplatin (92 mg/m2) with a simultaneous intravenous bolus of 5-fluorouracil (400 mg/m2) and leucovorin (20 mg/m2). After three rounds of bidirectional therapy, patients have received a maximum of three PIPACs.
PIPAC with oxaliplatin
During PIPAC, oxaliplatin (92 mg/m2) is aerosolized during a laparoscopic surgery with an average pressure of 12 mm Hg. After complete injection (5 minutes), electrostatic precipitation is applied by using CE-certified Ultravision technology. After electrostatic precipitation, the therapeutic capnoperitoneum is maintained for another 25 minutes.
Primary outcome(s): The number of patients with severe toxicity, measured up to 4 weeks after the last cycle of bidirectional therapy consisting of two/three cycles of systemic chemotherapy followed by a laparoscopic ePIPAC-OX procedure.
Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Other