The Effects of Preoperative Bevacizumab on Perioperative Complications

Colorectal Cancer Clinical Trial

Official title:

The Effects of Preoperative Bevacizumab on Perioperative Complications in Patients With Tumor Undergoing Unexpected Operation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04788381
• Other study ID #: RWS-CRC-LC-S
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Su Zhan Zhang, PhD
• Phone: 008613600511585
• Email: zrsj[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a nationwide multicenter,retrospective,observational real-world study.

1. To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation.

2. To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications.

3. To explore the risk factors of perioperative comlications in patients with tumor received bevacizumab prior to unexpected operation.

Description:

Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor(VEGF) in in vitro and in vivo assay systems. Bevacizumab was first granted marketing approval in the United States on 26 February 2004 (international birth date) in combination with IV 5-fluorouracil(5-FU) based chemotherapy for the first-line treatment of patients with metastatic carcinoma of the colon or rectum (CRC). At present, bevacizumab is widely used in the treatment of solid tumors such as lung cancer ,colorectal cancer and so on. It has been reported in the literature that bevacizumab may adversely affect wound healing. To prevent postoperative complications, some guidelines state that the interval time between last dose of bevacizumab and operations should be at least 6 weeks, but the optimal time to discontinue bevacizumab before surgery has not been confirmed. This project aims to evaluate the risk of perioperative complications in cancer patients with a history of bevacizumab use within 6 weeks prior to unexpected operation.

This is a nationwide multicenter,retrospective,observational real-world study.The study will collect the medical records and prognosis in 30 days following surgery of patients with colorectal cancer and lung cancer who underwent unexpected operation within 6 weeks (including 6 weeks) of bevacizumab discontinuation from 01 Jan 2010 to 31 Dec 2019.All enrolled subjects aged 18-90 years old; Complete clinical data related to important indicators, including preoperative baseline data, surgical information and perioperative prognosis information. The patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to surgery would be excluded.

Primary Evaluation Measures: To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation:to calculate the total incidence of perioperative complications in patients undergoing unexpected surgery after discontinuation of bevacizumab, including wound healing complications, non-wound-related infections, postoperative bleeding, thrombosis, gastrointestinal perforation, anastomotic leakage, secondary surgery, death and other perioperative adverse events;to calculate the incidence of each perioperative complication in patients undergoing unexpected operation after bevacizumab discontinuation.

SAS9.4 statistical analysis software will be used for analysis. Measurement indicators will be statistically described using number of cases, mean, median, standard deviation, minimum and maximum; categorical indicators will be statistically described using frequency and percentage. Unless otherwise specified, all statistical tests will adopt the two-sided test with α = 0.05, and the corresponding OR value and two-sided 95% confidence interval will be provided if applicable.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 1.Patients with colorectal cancer and lung cancer who underwent unexpected operation from 01 Jan 2010 to 31 Dec 2019, and received bevacizumab within 6 weeks (including 6 weeks) before operation;

• 2.Patients aged 18-90 years old;

• 3.Complete clinical data related to important indicators, including preoperative baseline data, surgical information and perioperative prognosis information.

Exclusion Criteria:

• Patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to unexcepted operation.

Related Conditions & MeSH terms

• Bevacizumab
• Colorectal Cancer
• Lung Cancer
• Operation Wound; Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Drug:
• Bevacizumab
Enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation.	To calculate the total incidence of perioperative complications in patients undergoing unexpected surgery after discontinuation of bevacizumab, including wound healing complications, non-wound-related infections, postoperative bleeding, thrombosis, gastrointestinal perforation, anastomotic leakage, secondary surgery, death and other perioperative adverse events;To calculate the incidence of each perioperative complication in patients undergoing unexpected operation after bevacizumab discontinuation.	30 days after operation
Secondary	To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications.	According to the interval between the last dose of preoperative bevacizumab and surgery, the patients were divided into three groups: within 2 weeks (including 2 weeks), 2 weeks to 4 weeks (including 4 weeks), and 4 weeks to 6 weeks (including 6 weeks). If the number of patients actually enrolled in each group was too small to support subsequent analysis, the grouping was adjusted according to the interval between the last dose of preoperative bevacizumab and surgery, such as two groups: within 4 weeks, 4 weeks to 6 weeks, or the possibility of other grouping, depending on the actual enrollment.	30 days after operation