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Completed

NCT Number: NCT02399410

Perioperative Chemotherapy With Bevacizumab 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perioperative chemotherapy plus bevacizumab

Drug

preoperative and postoperative combination chemotherapy with bevacizumab

cytoreductive surgery

Procedure

complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.

Intraperitoneal Oxaliplatin

Drug

Pump-driven intraperitoneal administration of oxaliplatin

Primary outcomes

  1. surgical morbidity and mortality

    Time frame: until 3 months after surgery and intraperitoneal chemotherapy

    This will be estimated with the Dindo-Clavien classification

Secondary outcomes

  1. progression free survival

    Time frame: 24 months after finishing the adjuvant chemotherapy

    time interval between date of surgery and disease progression or death

  2. overall survival

    Time frame: 24 months after finishing the adjuvant chemotherapy

    calculated from date of surgery until death

  3. treatment completion rate

    Time frame: day 1 after termination of adjuvant chemotherapy

    percentage of patients receiving all planned courses

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2015
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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