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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01277120
First received: January 13, 2011
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This single arm, prospective, observational study will assess the correlation be tween the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated m etastatic colorectal cancer. Patients will be followed for up to 12 months after progressive disease occurs.


Condition
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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

First-line treatment with Avastin

Criteria

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
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: NCT01277120

Locations
Romania
Bucharest, Romania, 022328
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: NCT01277120     History of Changes
Other Study ID Numbers: ML25178
Study First Received: January 13, 2011
Last Updated: October 13, 2014
Health Authority: Romania: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014