The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
preoperative and postoperative combination chemotherapy with bevacizumab
complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.
Pump-driven intraperitoneal administration of oxaliplatin
Ghent University Hospital
Ghent, Belgium
surgical morbidity and mortality
This will be estimated with the Dindo-Clavien classification
Time frame: until 3 months after surgery and intraperitoneal chemotherapy
progression free survival
time interval between date of surgery and disease progression or death
Time frame: 24 months after finishing the adjuvant chemotherapy
overall survival
calculated from date of surgery until death
Time frame: 24 months after finishing the adjuvant chemotherapy
treatment completion rate
percentage of patients receiving all planned courses
Time frame: day 1 after termination of adjuvant chemotherapy
chemotherapy-related toxicity
percentage of patients experiencing chemotherapy-related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) scoring system
Time frame: 1 month after termination of the adjuvant chemotherapy
pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab
will be scored with a 3 level regression scale
Time frame: day 1 after termination of the cytoreductive surgery
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