Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399410
• Other study ID #: EC/2014/1042
• Status: Completed
• Phase: Phase 2
• Start date: November 4, 2015
• Est. completion date: November 9, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical morbidity and mortality	This will be estimated with the Dindo-Clavien classification	until 3 months after surgery and intraperitoneal chemotherapy
Secondary	progression free survival	time interval between date of surgery and disease progression or death	24 months after finishing the adjuvant chemotherapy
Secondary	overall survival	calculated from date of surgery until death	24 months after finishing the adjuvant chemotherapy
Secondary	treatment completion rate	percentage of patients receiving all planned courses	day 1 after termination of adjuvant chemotherapy
Secondary	chemotherapy-related toxicity	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
Secondary	pathological gross response of peritoneal tumour deposits to neoadjuvant combination chemotherapy with bevacizumab	will be scored with a 3 level regression scale	day 1 after termination of the cytoreductive surgery