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

Colorectal Cancer Clinical Trial

Official title:

A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266564
• Other study ID #: ML25198
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: August 10, 2017
• Start date: September 3, 2010
• Est. completion date: July 10, 2015

Study information

• Verified date: August 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: July 10, 2015
• Est. primary completion date: July 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Lebanon	Al-Rassoul Al-Aazam Hospital	Beirut
Lebanon	American University of Beirut - Medical Center	Beirut
Lebanon	Beirut Governmental University Hospital	Beirut
Lebanon	Hotel Dieu de France; Oncology	Beirut
Lebanon	Lebanese Hospital Geitaoui	Beirut
Lebanon	Middle East Inst. of Health; Oncology	Beirut
Lebanon	Mount Lebanon Hospital	Beirut
Lebanon	Saint George Hospital; Haematology-Oncology	Beirut
Lebanon	Saint Joseph Hospital	Dora
Lebanon	Ain Wa Zein Hospital	El Chouf
Lebanon	Bellevue Medical Center	El- Metn
Lebanon	Notre Dame Des Secours Hospital	Jbeil
Lebanon	Hammoud Hospital	Saida
Lebanon	Haykal Hospital	Tripoli

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival in a real life setting assessed by computer tomography		Approximately 2 years
Secondary	Overall response rate assessed by computer tomography		Approximately 2 years
Secondary	Response of Avastin according to the sites of metastases assessed by computer tomography		Approximately 2 years
Secondary	Chemotherapy regimens used in combination with Avastin		Approximately 2 years
Secondary	Patient demographics eligible to receive Avastin		Approximately 2 years
Secondary	Safety: incidence of adverse events		Approximately 2 years