Clinical trial NCT01266564: An Observational Study of Avastin (Bevacizumab) in Patients With Colorectal Cancer
Official title: A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Colorectal cancer patients receiving Avastin in combination with chemotherapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival in a real life setting assessed by computer tomography
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Overall response rate assessed by computer tomography
timeFrame: Approximately 2 years
measure: Response of Avastin according to the sites of metastases assessed by computer tomography
timeFrame: Approximately 2 years
measure: Chemotherapy regimens used in combination with Avastin
timeFrame: Approximately 2 years
measure: Patient demographics eligible to receive Avastin
timeFrame: Approximately 2 years
measure: Safety: incidence of adverse events
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut - Medical Center
city: Beirut
country: Lebanon
facility: Saint George Hospital; Haematology-Oncology
city: Beirut
country: Lebanon
facility: Hotel Dieu de France; Oncology
city: Beirut
country: Lebanon
facility: Mount Lebanon Hospital
city: Beirut
country: Lebanon
facility: Beirut Governmental University Hospital
city: Beirut
country: Lebanon
facility: Al-Rassoul Al-Aazam Hospital
city: Beirut
country: Lebanon
facility: Lebanese Hospital Geitaoui
city: Beirut
country: Lebanon
facility: Middle East Inst. of Health; Oncology
city: Dora
country: Lebanon
facility: Saint Joseph Hospital
city: El Chouf
country: Lebanon
facility: Ain Wa Zein Hospital
city: El- Metn
country: Lebanon
facility: Bellevue Medical Center
city: Jbeil
country: Lebanon
facility: Notre Dame Des Secours Hospital
city: Saida
country: Lebanon
facility: Hammoud Hospital
city: Tripoli
country: Lebanon
facility: Haykal Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: