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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 23, 2013
Last updated: August 1, 2016
Last verified: August 2016
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.

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 ]

Secondary Outcome Measures:
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: 5 years ]
  • Progression-free survival in daily routine [ Time Frame: 5 years ]
  • Overall response in daily routine [ Time Frame: 5 years ]
  • Response rate in daily routine [ Time Frame: 5 years ]
  • Treatment schemes in daily routine [ Time Frame: 5 years ]
  • Safety: incidence of adverse events [ Time Frame: 5 years ]
  • Reason for treatment modifications/discontinuation [ Time Frame: 5 years ]

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)


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
Patients with Metastatic colorectal cancer

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 identifier: NCT01775644

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01775644     History of Changes
Other Study ID Numbers: ML28120
Study First Received: January 23, 2013
Last Updated: August 1, 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on May 25, 2017