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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)

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ClinicalTrials.gov Identifier: NCT01277120
Recruitment Status : Terminated (Contract terminated with Site Management Organization)
First Posted : January 14, 2011
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Colorectal Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 174 participants
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)
Study Start Date : April 2010
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Cohort


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Overall survival [ Time Frame: 60 months ]
  2. Safety: Incidence of adverse events [ Time Frame: 60 months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277120


Locations
Romania
Bucharest, Romania, 022328
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01277120     History of Changes
Other Study ID Numbers: ML25178
First Posted: January 14, 2011    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

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