Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

January 29, 2024 updated by: University Hospital, Ghent

BEV-IP: Perioperative Chemotherapy With Bevacizumab in Patients Undergoing Cytoreduction and Intraperitoneal Chemoperfusion for Colorectal Carcinomatosis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bevacizumab and CRS with oxaliplatin
Perioperative chemotherapy plus bevacizumab and CRS with oxaliplatin
Drug: perioperative chemotherapy plus bevacizumab
preoperative and postoperative combination chemotherapy with bevacizumab
Procedure: cytoreductive surgery
complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.
Drug: Intraperitoneal Oxaliplatin
Pump-driven intraperitoneal administration of oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical morbidity and mortality
Time Frame: until 3 months after surgery and intraperitoneal chemotherapy
This will be estimated with the Dindo-Clavien classification
until 3 months after surgery and intraperitoneal chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 24 months after finishing the adjuvant chemotherapy
time interval between date of surgery and disease progression or death
24 months after finishing the adjuvant chemotherapy
overall survival
Time Frame: 24 months after finishing the adjuvant chemotherapy
calculated from date of surgery until death
24 months after finishing the adjuvant chemotherapy
treatment completion rate
Time Frame: day 1 after termination of adjuvant chemotherapy
percentage of patients receiving all planned courses
day 1 after termination of adjuvant chemotherapy
chemotherapy-related toxicity
Time Frame: 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
1 month after termination of the adjuvant chemotherapy
pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab
Time Frame: day 1 after termination of the cytoreductive surgery
will be scored with a 3 level regression scale
day 1 after termination of the cytoreductive surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Wim P Ceelen, MD,PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2015

Primary Completion (Actual)

November 9, 2023

Study Completion (Actual)

November 9, 2023

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimated)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2014/1042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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