An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer
A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
1 other identifier
observational
205
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2010
CompletedFirst Submitted
Initial submission to the registry
December 20, 2010
CompletedFirst Posted
Study publicly available on registry
December 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2015
CompletedAugust 11, 2017
August 1, 2017
4.9 years
December 20, 2010
August 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival in a real life setting assessed by computer tomography
Approximately 2 years
Secondary Outcomes (5)
Overall response rate assessed by computer tomography
Approximately 2 years
Response of Avastin according to the sites of metastases assessed by computer tomography
Approximately 2 years
Chemotherapy regimens used in combination with Avastin
Approximately 2 years
Patient demographics eligible to receive Avastin
Approximately 2 years
Safety: incidence of adverse events
Approximately 2 years
Study Arms (1)
Cohort
Eligibility Criteria
Colorectal cancer patients receiving Avastin in combination with chemotherapy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
American University of Beirut - Medical Center
Beirut, 11-236, Lebanon
Saint George Hospital; Haematology-Oncology
Beirut, 166378, Lebanon
Hotel Dieu de France; Oncology
Beirut, 16830, Lebanon
Mount Lebanon Hospital
Beirut, 470 Hazmieh, Lebanon
Beirut Governmental University Hospital
Beirut, 99999, Lebanon
Al-Rassoul Al-Aazam Hospital
Beirut, Lebanon
Lebanese Hospital Geitaoui
Beirut, Lebanon
Middle East Inst. of Health; Oncology
Beirut, Lebanon
Notre Dame Des Secours Hospital
Byblos, 1401, Lebanon
Saint Joseph Hospital
Ed Daoura, Lebanon
Ain Wa Zein Hospital
El Chouf, 1503-2010, Lebanon
Bellevue Medical Center
El- Metn, 295, Lebanon
Hammoud Hospital
Saida, 652, Lebanon
Haykal Hospital
Tripoli, 371 Tripoli, Lebanon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2010
First Posted
December 24, 2010
Study Start
September 3, 2010
Primary Completion
July 10, 2015
Study Completion
July 10, 2015
Last Updated
August 11, 2017
Record last verified: 2017-08