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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01775644
First received: January 23, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observastonal multicenter study will evaluate the differences of progressio n-free survival in defined subgroups of patients with metastatic colorectal canc er receiving Avastin (bevacizumab). Further, safety and efficacy in daily routin e 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 ]

Estimated Enrollment: 3000
Study Start Date: December 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Reference Study ID Number: ML28120 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

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

No publications provided

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 4, 2014
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

ClinicalTrials.gov processed this record on August 18, 2014