Colorectal CancerNCT01266564
An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 14 sites in Lebanon.
Trial summary
This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 205 participants
- Where
- 14 sitesLebanon
- Study dates
- 3 Sep 2010to 10 Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal cancer patients receiving Avastin in combination with chemotherapy
Who may be able to join
- Adult patients, age >/=18 years
- Proven metastatic colorectal carcinoma
- Patients have measurable disease
- Patients are eligible to receive first-line Avastin
- Patients have signed data release form
Who cannot join
- Contra-indication to receive Avastin according to the local labeling
- Participation in a clinical study within 30 days prior to enrolment
- Patients have any other primary cancer
- Concomitant treatment with other biologics
- History of other malignant disease in the past 5 years except basal cell carcinoma
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Lebanon14 sites
American University of Beirut - Medical Center
Beirut, 11-236
Saint George Hospital; Haematology-Oncology
Beirut, 166378
Hotel Dieu de France; Oncology
Beirut, 16830
Mount Lebanon Hospital
Beirut, 470 Hazmieh
Beirut Governmental University Hospital
Beirut, 99999
Al-Rassoul Al-Aazam Hospital
Beirut
Lebanese Hospital Geitaoui
Beirut
Middle East Inst. of Health; Oncology
Beirut
Notre Dame Des Secours Hospital
Byblos, 1401
Saint Joseph Hospital
Ed Daoura
Ain Wa Zein Hospital
El Chouf, 1503-2010
Bellevue Medical Center
El- Metn, 295
Hammoud Hospital
Saida, 652
Haykal Hospital
Tripoli, 371 Tripoli
About this study
Official title: A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
This observational study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival in a real life setting assessed by computer tomography
Measured: Approximately 2 years
Secondary outcomes (5)
Overall response rate assessed by computer tomography
Measured: Approximately 2 years
Response of Avastin according to the sites of metastases assessed by computer tomography
Measured: Approximately 2 years
Chemotherapy regimens used in combination with Avastin
Measured: Approximately 2 years
Patient demographics eligible to receive Avastin
Measured: Approximately 2 years
Safety: incidence of adverse events
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study start3 Sep 2010
- Primary completion10 Jul 2015
- Study completion10 Jul 2015
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 Hoffmann-La RocheThe 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
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266564
- Sponsor's protocol ID
- ML25198
- Status last verified
- Aug 2017
- First submitted
- 20 Dec 2010
- Last updated
- 11 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01266564
- Acronym / sponsor ID
- ML25198
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2010 (actual)
- Primary completion
- 10 Jul 2015 (actual)
- Study completion
- 10 Jul 2015 (actual)
- First posted
- 24 Dec 2010 (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 study will assess the progression-free survival, overall response and safety of Avastin (bevacizumab) in combination with chemotherapy in a real life setting in patients with metastatic colorectal cancer. Data will be collected from patients for approximately 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients receiving Avastin in combination with chemotherapy
Key inclusion criteria (5 listed)
- Adult patients, age >/=18 years
- Proven metastatic colorectal carcinoma
- Patients have measurable disease
- Patients are eligible to receive first-line Avastin
- Patients have signed data release form
Key exclusion criteria (5 listed)
- Contra-indication to receive Avastin according to the local labeling
- Participation in a clinical study within 30 days prior to enrolment
- Patients have any other primary cancer
- Concomitant treatment with other biologics
- History of other malignant disease in the past 5 years except basal cell carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival in a real life setting assessed by computer tomography
Time frame: Approximately 2 years
5 secondary outcomes
Overall response rate assessed by computer tomography
Time frame: Approximately 2 years
Response of Avastin according to the sites of metastases assessed by computer tomography
Time frame: Approximately 2 years
Chemotherapy regimens used in combination with Avastin
Time frame: Approximately 2 years
Patient demographics eligible to receive Avastin
Time frame: Approximately 2 years
Safety: incidence of adverse events
Time frame: Approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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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.
Clinical Trials study director
Hoffmann-La Roche
14 sites 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, run by Hoffmann-La Roche at 14 sites in Lebanon.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival in a real life setting assessed by computer tomography (time frame: Approximately 2 years). 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 11 Aug 2017.