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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01775644
First received: January 23, 2013
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
This observastonal multicenter study will evaluate the differences of progression-free survival in defined subgroups of patients with metastatic colorectal cancer receiving Avastin (bevacizumab). Further, safety and efficacy in daily routine will be assessed. Data will be collected for up to 5 years.

Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study of Avastin® First-line in Metastatic Colorectal Cancer (Koralle)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Differences in progression-free survival of patient subgroups [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival in daily routine [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall response in daily routine [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Response rate in daily routine [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Treatment schemes in daily routine [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Reason for treatment modifications/discontinuation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 2947
Study Start Date: December 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Metastatic colorectal cancer
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Patients with metastatic colorectal cancer where investigators have decided to give a first-line, fluoro-pyrimidine-based combination therapy with Avastin® according to Summary of Product Characteristics (SmPC)
  • Written and signed informed consent prior to onset of documentation

Exclusion Criteria:

  • Contraindications for Avastin® according to Summary of Products Characteristics (SmPC)
  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: NCT01775644

Locations
Germany
Freiburg, Germany, 79106
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01775644     History of Changes
Other Study ID Numbers: ML28120 
Study First Received: January 23, 2013
Last Updated: August 1, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices(Bfarm)

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 December 02, 2016