Metastatic Colorectal CancerNCT01860144
An Observational Study of Bevacizumab in Chinese Patients With Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer, run by Peking University at 1 site in China.
Trial summary
This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with 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
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2015
- How long will I take part?
- 2 Years
- 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: metastatic colorectal cancer patients accept bevacizumab
Who may be able to join
- histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab
Who cannot join
- non-metastatic colorectal cancer patients not recieved bevacizumab
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, M.D., 861088196561, lin100@medmail.com.cn
About this study
This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Bevacizumab
- Keywords
- bevacizumab, overall survival, adverse events, tumor resection rate
- 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
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Patients with metastatic colorectal cancer who accept treatment with chemotherapy and bevacizumab Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
To evaluate the treatment response of bevacizumab in Chinese patients with mCRC in real clinical practice
Measured: 6 weeks
Secondary outcomes (4)
overall survival
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
Measured: 3 months
progression free survival
the follow-up visit of PFS will be performed every 6 weeks
Measured: 6 weeks
Proportion of patients with bevacizumab treatment discontinuation
Proportion of patients with bevacizumab treatment discontinuation due to bevacizumab-related adverse events
Measured: 3 weeks
resection rate
resection rate of tumor after chemotherapy plus bevacizumab
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (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 Peking 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
- 250 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, M.D., Principal investigator, Beijing Cancer Hopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860144
- Sponsor's protocol ID
- CGOG2001
- Status last verified
- May 2015
- First submitted
- 19 May 2013
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Bevacizumab in Chinese Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01860144
- Acronym / sponsor ID
- CGOG2001
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- bevacizumab, overall survival, adverse events, tumor resection rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 May 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.
This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with metastatic colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | – | Drug: BevacizumabPatients with metastatic colorectal cancer who accept treatment with chemotherapy and bevacizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- metastatic colorectal cancer patients accept bevacizumab
Key inclusion criteria (1 listed)
- histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab
Key exclusion criteria (1 listed)
- non-metastatic colorectal cancer patients not recieved bevacizumab
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: avastin | Drug | bevacizumab |
Primary outcome
Objective response rate
Time frame: 6 weeks
To evaluate the treatment response of bevacizumab in Chinese patients with mCRC in real clinical practice
4 secondary outcomes
overall survival
Time frame: 3 months
progression free survival
Time frame: 6 weeks
Proportion of patients with bevacizumab treatment discontinuation
Time frame: 3 weeks
resection rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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CRC
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.
Lin Shen, M.D. principal investigator
Beijing Cancer Hopital
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 Metastatic Colorectal Cancer, run by Peking University 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 1 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 19 May 2015. 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 Lin Shen, M.D. (861088196561, lin100@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 weeks). 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 19 May 2015.