The Effects of Preoperative Bevacizumab on Perioperative Complications

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Lung Cancer; Bevacizumab; Operation Wound; Infection
• Intervention / Treatment: Drug: Bevacizumab

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Su Zhan Zhang, PhD; Phone Number: 008613600511585; Email: zrsj@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 0571
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Zhang Su Zhan, Doctor; Phone Number: 008613600511585; Email: zrsj@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with colorectal canceror lung cancer who underwent unexpected operation within 6 weeks (including 6 weeks) of bevacizumab discontinuation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with CRC or lung cancer was performed unexpected operation; This is an observational study; thus, no intervention or treatment is required by the protocol. During the study, enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation.	Drug: Bevacizumab; Enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation.; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Su Zhan Zhang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): May 31, 2021
• Study Completion (ANTICIPATED): July 31, 2021

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (ACTUAL): March 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: bevacizumab
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Surgical Wound Infection; Wound Infection; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: RWS-CRC-LC-S

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No