Metastatic Colorectal CancerNCT01912443
Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by Sun Yat-sen University at 7 sites in China.
Trial summary
To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 7 sitesChina
- Study dates
- Aug 2013to Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with histologically confirmed metastatic colorectal cancer are eligible
Who may be able to join
- with histologically confirmed metastatic colorectal cancer
- patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment
- Written informed consent
- Unlimited line of treatment (first-line or second line is not limited)
Who cannot join
- Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert:
- Recent history of serious hemorrhage or hemoptysis of ≥1/2 teaspoon of red blood
- Proteinuria at baseline: Patients discovered to have ≥ 2 grams of proteinuria/24 hours *
- The measurement of 24-hour proteinuria level is recommended for patients with moderate to high proteinuria risk indicated by clinical judgement. The treatment with bevacizumab should be delayed when proteinuria is ≥2g/24 hours.
- Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds
- Pregnant or lactating women
- Excluding patients known to be allergic to bevacizumab or any of the excipients
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
First Affiliated Hospital of PLA General Hospital
Beijing, 100048
Nan Du, Doctor, dunan304@163.com
Nan Qi, Doctor, 18810494306@126.com
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Guanghai Dai, Master, daigh60@sohu.com
Hui Mao, Doctor, michaelia814105@hotmail.com
- Recruiting
The Second People's Hospital of Sichuan
Chengdu, Sichuan, 610041
Jin Yan, Bachelor degree, Yanjin-1111@163.com
Yangchun Zheng, Doctor, zheng-ych@sohu.com
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
Ruihua Xu, Professor
- Recruiting
Liaoning Cancer Hosptial & Institute
Shenyang, Liaoning, 110042
Baoli Qin, Doctor, poryqin@aliyun.com
Zhongmiao Wang, Master, wangzhongmiao@126.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Jianjun Yang, Doctor, nkyang@126.com
Shuna Yao, Doctor, yaoshunan07@126.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Qingxia Fan, Doctor, 13939039058@126.com
Wei He, Doctor, hewei726@126.com
About this study
To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer
Read the detailed description
This is a multi-centre, observational, non-interventional study. Patients with metastatic colorectal cancer eligible for Bevacizumab in combination with chemotherapy treatment will be enrolled in this trial.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Also called Avastin
5 mg/Kg, IV (in the vein) on day 1 and day 14 of each 28 day cycle. Number of Cycles: until progression.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab Plus Chemotherapy | Not described Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature and severity of adverse events of special interest
Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria
Measured: Four years
Incidence, nature and severity of bevacizumab related serious adverse events
Measured: Four years
Onset time of adverse event associated with bevacizumab
Measured: Four years
Laboratory parameters
Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein
Measured: Four years
Secondary outcomes (6)
Overall survival (OS)
Time from the diagnosis of colorectal cancer to death due to various causes. Patients who do not die at the end of study will be truncated when they do not die at the last collection.
Measured: Four years
Overall response rate (ORR) of treatment line
The best overall response status determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is defined as the best response status recorded from the enrollment to disease progression (the minimal measurement from baseline assessment is used as the reference for progression). ORR includes complete response (CR) and partial response (PR). The value of change will be summarized according to different treatment lines.
Measured: Four years
Progression-free survival (PFS) of treatment line:
Time from the enrollment to disease progression or death due to various causes, whichever is earlier (Disease progression is according to RECIST 1.1 criteria for tumor assessment). Patients who do not have disease progression or death at the end of study will be truncated at the last tumor assessment. The value of change will be summarized according to different treatment lines.
Measured: Four years
One-year disease-free progression rate of treatment line
The proportion of patients without disease progression within one year since enrollment or with death for other reasons based on analytical population. The value of change will be summarized according to different treatment lines.
Measured: One year
One-year survival rate of treatment line
The proportion of patients without death within one year since enrollment based on analytical population. The value of change will be summarized according to different treatment lines.
Measured: One year
Overall survival (OS) of treatment line
Time from the enrollment to death due to various causes. Patients who do not die at the end of study will be truncated when they do not die at the last collection.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Proswell Medical Corporation
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912443
- Sponsor's protocol ID
- ML28629
- Status last verified
- Apr 2014
- First submitted
- 24 Jul 2013
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01912443
- Acronym / sponsor ID
- ML28629
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Proswell Medical Corporation
- Study start
- Aug 2013
- Primary completion
- Aug 2017 (estimated)
- First posted
- 31 Jul 2013 (estimated)
- 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.
To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer
Detailed description
This is a multi-centre, observational, non-interventional study. Patients with metastatic colorectal cancer eligible for Bevacizumab in combination with chemotherapy treatment will be enrolled in this trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab Plus Chemotherapy | – | Drug: bevacizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with histologically confirmed metastatic colorectal cancer are eligible
Key inclusion criteria (4 listed)
- with histologically confirmed metastatic colorectal cancer
- patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment
- Written informed consent
- Unlimited line of treatment (first-line or second line is not limited)
Key exclusion criteria (7 listed)
- Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert:
- Recent history of serious hemorrhage or hemoptysis of ≥1/2 teaspoon of red blood
- Proteinuria at baseline: Patients discovered to have ≥ 2 grams of proteinuria/24 hours *
- Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds
- Pregnant or lactating women
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: Avastin5 mg/Kg, IV (in the vein) on day 1 and day 14 of each 28 day cycle. Number of Cycles: until progression. | Drug | Bevacizumab Plus Chemotherapy |
Primary outcome
Incidence, nature and severity of adverse events of special interest
Time frame: Four years
Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria
Incidence, nature and severity of bevacizumab related serious adverse events
Time frame: Four years
Onset time of adverse event associated with bevacizumab
Time frame: Four years
Laboratory parameters
Time frame: Four years
Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein
6 secondary outcomes
Overall survival (OS)
Time frame: Four years
Overall response rate (ORR) of treatment line
Time frame: Four years
Progression-free survival (PFS) of treatment line:
Time frame: Four years
One-year disease-free progression rate of treatment line
Time frame: One year
One-year survival rate of treatment line
Time frame: One year
Overall survival (OS) of treatment line
Time frame: Four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Sun Yat-sen University at 7 sites 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 4 inclusion and 7 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 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Ruihua Xu, Professor (+86-20-87343804, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature and severity of adverse events of special interest (time frame: Four years). The study lists 4 primary outcomes in all. 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 28 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.