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An Observational Study on The Correlation Between Time of Initiation of Avastin (Bevacizumab) Treatment And Progression-Free Survival in Patients With Colorectal Cancer (CRONOS 1)

This study has been terminated.
(Contract terminated with Site Management Organization)
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 13, 2011
Last updated: September 14, 2016
Last verified: September 2016
This single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic colorectal cancer. Patients will be followed for up to 12 months after progressive disease occurs.

Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Correlation Between the Moment of Bevacizumab theRapy initiatiOn and the Efficacy in patieNt With cOlorectal Cancer Treated With AvaStin Based First Line Regimens (CRONOS 1)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Correlation of the time from the start of chemotherapy to the start of Avastin treatment with progression-free survival [ Time Frame: 60 months ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 60 months ]
  • Safety: Incidence of adverse events [ Time Frame: 60 months ]

Enrollment: 174
Study Start Date: April 2010
Study Completion Date: April 2016
Primary Completion Date: April 2016 (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
First-line treatment with Avastin

Inclusion Criteria:

  • Adult patients, >/= the 18 years of age
  • Previously untreated metastatic colorectal cancer
  • Scheduled to start 1st line chemotherapeutic treatment
  • ECOG performance status 0-1

Exclusion Criteria:

  • Any conditions included in contraindication list for Avastin
  • Prior chemotherapy for metastatic colorectal cancer
  • Adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic colorectal cancer completed <6 months prior to treatment start
  Contacts and Locations
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Please refer to this study by its identifier: NCT01277120

Bucharest, Romania, 022328
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01277120     History of Changes
Other Study ID Numbers: ML25178
Study First Received: January 13, 2011
Last Updated: September 14, 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 August 22, 2017