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Completed

NCT Number: NCT01266564

An Observational Study of Avastin (Bevacizumab) in Patients With 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Rassoul Al-Aazam Hospital, Beirut, Lebanon

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression-free survival in a real life setting assessed by computer tomography

    Time frame: Approximately 2 years

Secondary outcomes

  1. Overall response rate assessed by computer tomography

    Time frame: Approximately 2 years

  2. Response of Avastin according to the sites of metastases assessed by computer tomography

    Time frame: Approximately 2 years

  3. Chemotherapy regimens used in combination with Avastin

    Time frame: Approximately 2 years

  4. Patient demographics eligible to receive Avastin

    Time frame: Approximately 2 years

  5. Safety: incidence of adverse events

    Time frame: Approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2010
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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