Colorectal CancerNCT04788381
The Effects of Preoperative Bevacizumab on Perioperative Complications
An observational study of Colorectal Cancer and Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer, Lung Cancer, Operation Wound; Infection
- What is being tested?
- Bevacizumab
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with colorectal canceror lung cancer who underwent unexpected operation within 6 weeks (including 6 weeks) of bevacizumab discontinuation.
Who may be able to join
- 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.
Who cannot join
- Patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to unexcepted operation.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 0571
Zhang Su Zhan, Doctor, 008613600511585, zrsj@zju.edu.cn
About this study
Official title: 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.
- To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation.
- To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications.
- To explore the risk factors of perioperative comlications in patients with tumor received bevacizumab prior to unexpected operation.
Read the 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.
- Being tested
- Bevacizumab
- Keywords
- bevacizumab
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after operation
Secondary outcomes (1)
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.
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzhanzhang, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Su Zhan Zhang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788381
- Sponsor's protocol ID
- RWS-CRC-LC-S
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Bevacizumab on Perioperative Complications in Patients With Tumor Undergoing Unexpected Operation
- ClinicalTrials.gov ID
- NCT04788381
- Acronym / sponsor ID
- RWS-CRC-LC-S
- Keywords
- bevacizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a nationwide multicenter,retrospective,observational real-world study.
- To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation.
- To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications.
- To explore the risk factors of perioperative comlications in patients with tumor received bevacizumab prior to unexpected operation.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with CRC or lung cancer was performed unexpected operation | – | Drug: BevacizumabThis 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with colorectal canceror lung cancer who underwent unexpected operation within 6 weeks (including 6 weeks) of bevacizumab discontinuation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who used anti-angiogenic agents other than bevacizumab within 6 weeks prior to unexcepted operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinEnrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation. | Drug | Participants with CRC or lung cancer was performed unexpected operation |
Primary outcome
To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation.
Time frame: 30 days after 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.
1 secondary outcome
To assess the correlation of the interval time between the last dose of bevacizumab and operation and occurrence of perioperative complications.
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su Zhan Zhang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Zhan Zhang, PhD (008613600511585, zrsj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the risk of perioperative complications in patients with tumor who received bevacizumab prior to unexpected operation. (time frame: 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.