Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

Phase 2

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: perioperative chemotherapy plus bevacizumab; Procedure: cytoreductive surgery; Drug: Intraperitoneal Oxaliplatin

• Registration Number: NCT02399410
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-26
• Study Start: 2015-11-04
• Primary Completion: 2023-11-09
• Study Completion: 2023-11-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• biopsy proven adenocarcinoma of the colon or rectum and synchronous or metachronous peritoneal carcinomatosis.
• absence of systemic disease, with the exception of small, superficial liver metastases, requiring only minor surgery.
• resectable disease at staging, during laparoscopic evaluation and during exploration for cytoreductive surgery and intraperitoneal chemotherapy.
• complete macroscopic cytoreduction at the time of surgery (CC-0/1)
• good general health status (Karnofsky index > 70%)
• expected life expectancy more than 6 months
• no other malignancy than disease under study
• serum creatinine < 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m
• serum total bilirubin < 1.5 mg/dl
• platelet count > 100,000/ml
• hemoglobin > 9g/dl
• neutrophil granulocytes > 1,500/ml
• International Normalized Ration (INR) 2 or < 2
• Absence of alcohol and/or drug abuse
• No inclusion in other clinical trials interfering with the study protocol
• No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
• Absence of heart failure (NYHA 2 or > 2) or significant coronary artery disease
• No pregnancy or breast feeding
• Adequate contraception in fertile patients

Exclusion Criteria

• No written informed consent
• tumour in the presence of obstruction
• evidence of extra-abdominal disease or extensive liver metastasis
• peritoneal cancer index > 25
• active bacterial, viral or fungal infection
• active gastro-duodenal ulcer
• parenchymal liver disease (any stage cirrhosis)
• uncontrolled diabetes mellitus
• severe obstructive or restrictive respiratory insufficiency
• psychiatric pathology capable of affecting comprehension and judgment faculty
• Known allergy to oxaliplatin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bevacizumab and CRS with oxaliplatin	cytoreductive surgery	Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
bevacizumab and CRS with oxaliplatin	perioperative chemotherapy plus bevacizumab	Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
bevacizumab and CRS with oxaliplatin	Intraperitoneal Oxaliplatin	Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin

Primary Outcome Measures

Name	Time	Method
surgical morbidity and mortality	until 3 months after surgery and intraperitoneal chemotherapy	This will be estimated with the Dindo-Clavien classification

Secondary Outcome Measures

Name	Time	Method
progression free survival	24 months after finishing the adjuvant chemotherapy	time interval between date of surgery and disease progression or death
treatment completion rate	day 1 after termination of adjuvant chemotherapy	percentage of patients receiving all planned courses
overall survival	24 months after finishing the adjuvant chemotherapy	calculated from date of surgery until death
chemotherapy-related toxicity	1 month after termination of the adjuvant chemotherapy	percentage of patients experiencing chemotherapy-related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) scoring system
pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab	day 1 after termination of the cytoreductive surgery	will be scored with a 3 level regression scale

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Gent, Belgium