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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01266564
First received: December 20, 2010
Last updated: August 10, 2017
Last verified: August 2017
  Purpose
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.

Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Multicenter Study of First-line Avastin® (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival in a real life setting assessed by computer tomography [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures:
  • Overall response rate assessed by computer tomography [ Time Frame: Approximately 2 years ]
  • Response of Avastin according to the sites of metastases assessed by computer tomography [ Time Frame: Approximately 2 years ]
  • Chemotherapy regimens used in combination with Avastin [ Time Frame: Approximately 2 years ]
  • Patient demographics eligible to receive Avastin [ Time Frame: Approximately 2 years ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 2 years ]

Enrollment: 205
Actual Study Start Date: September 3, 2010
Study Completion Date: July 10, 2015
Primary Completion Date: July 10, 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Colorectal cancer patients receiving Avastin in combination with chemotherapy
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266564

Locations
Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon, 11-236
Saint George Hospital; Haematology-Oncology
Beirut, Lebanon, 166378
Hotel Dieu de France; Oncology
Beirut, Lebanon, 16830
Mount Lebanon Hospital
Beirut, Lebanon, 470 Hazmieh
Beirut Governmental University Hospital
Beirut, Lebanon, 99999
Al-Rassoul Al-Aazam Hospital
Beirut, Lebanon
Lebanese Hospital Geitaoui
Beirut, Lebanon
Middle East Inst. of Health; Oncology
Beirut, Lebanon
Saint Joseph Hospital
Dora, Lebanon
Ain Wa Zein Hospital
El Chouf, Lebanon, 1503-2010
Bellevue Medical Center
El- Metn, Lebanon, 295
Notre Dame Des Secours Hospital
Jbeil, Lebanon, 1401
Hammoud Hospital
Saida, Lebanon, 652
Haykal Hospital
Tripoli, Lebanon, 371 Tripoli
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01266564     History of Changes
Other Study ID Numbers: ML25198
Study First Received: December 20, 2010
Last Updated: August 10, 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 19, 2017