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
- Diseases
- Colorectal cancer
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.