An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT01266564
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-03
• Study First Submitted: 2010-12-20
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-24
• Primary Completion: 2015-07-10
• Study Completion: 2015-07-10
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival in a real life setting assessed by computer tomography	Approximately 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

Hotel Dieu de France; Oncology; 🇱🇧 Beirut, Lebanon

Haykal Hospital; 🇱🇧 Tripoli, Lebanon

Beirut Governmental University Hospital; 🇱🇧 Beirut, Lebanon

Mount Lebanon Hospital; 🇱🇧 Beirut, Lebanon

Al-Rassoul Al-Aazam Hospital; 🇱🇧 Beirut, Lebanon

Saint Joseph Hospital; 🇱🇧 Dora, Lebanon

American University of Beirut - Medical Center; 🇱🇧 Beirut, Lebanon

Saint George Hospital; Haematology-Oncology; 🇱🇧 Beirut, Lebanon

Lebanese Hospital Geitaoui; 🇱🇧 Beirut, Lebanon

Middle East Inst. of Health; Oncology; 🇱🇧 Beirut, Lebanon

Ain Wa Zein Hospital; 🇱🇧 El Chouf, Lebanon

Bellevue Medical Center; 🇱🇧 El- Metn, Lebanon

Hammoud Hospital; 🇱🇧 Saida, Lebanon

Notre Dame Des Secours Hospital; 🇱🇧 Jbeil, Lebanon