Selected patients with peritoneal carcinomatosis (PC) from colorectal cancer (CRC) benefit from cytoreductive surgery (CRS) combined with intraperitoneal chemoperfusion (IPC). However, even after optimal cytoreduction, systemic and locoregional recurrence are common. Perioperative chemotherapy with bevacizumab (BEV) may improve the outcome of these patients. The BEV-IP study is a phase II, single-arm, open-label study aimed at patients with colorectal or appendiceal adenocarcinoma with synchronous or metachronous PC. This study evaluates whether perioperative chemotherapy including BEV in combination with CRS and oxaliplatin-based IPC results in acceptable morbidity and mortality (primary composite endpoint). Secondary endpoints are treatment completion rate, chemotherapy-related toxicity, pathological response, progression free survival, and overall survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Procedure/Surgery: Cytoreductive surgery combined with HIPEC (Oxaliplatin 360 mg/m2).
bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).
Number of participants with treatment related Adverse events grade IIIb or higher grade as assessed by Dindo-Clavien classification
Major morbidity (grade IIIb or higher grade complication according to Dindo-Clavien classification)
Time frame: Until 3 months after surgery and intraperitoneal chemotherapy
Number of participants with treatement related Adverse events less than grade IIIb as assessed by Dindo-Clavien classification
Minor morbidity (less than grade IIIb complication according to Dindo-Clavien classification).
Time frame: Until 3 months after surgery and intraperitoneal chemotherapy
Potential chemotherapy related morbidity
Adverse events will be described using MedDRA terms (version 18.0) and graded according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Time frame: During the first 60 postoperative days
Overall survival
calculated from date of surgery until death
Time frame: 24 months after finishing the adjuvant chemotherapy
Progression free survival
Time interval between date of surgery and disease progression or death
Time frame: 24 months after finishing the adjuvant chemotherapy
Pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab
Scored with a 3 level regression scale
Time frame: Day 1 after termination of the cytoreductive surgery
Quality of life assessment
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Using the EORTC QLQ-C30 questionnaires
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
Quality of life assessment
Using SF 36 questionnaires
Time frame: 24 months after finishing the adjuvant chemotherapy