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NCT02399410CompletedPhase 2

Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

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

Source: ClinicalTrials.gov · Last updated 30 Jan 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (actual)
First submitted
9 Mar 2015
Start date
4 Nov 2015
Primary completion date
9 Nov 2023
Lead sponsor
University Hospital, Ghent
NCT number
NCT02399410

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 60
  • From 4 Nov 2015 to the primary completion date, 9 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • No written informed consent
  • tumour in the presence of obstruction

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ghent university hospital
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.