Study Stopped
Contract terminated with Site Management Organization
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)
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)
1 other identifier
observational
174
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 13, 2011
CompletedFirst Posted
Study publicly available on registry
January 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedSeptember 15, 2016
September 1, 2016
6 years
January 13, 2011
September 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation of the time from the start of chemotherapy to the start of Avastin treatment with progression-free survival
60 months
Secondary Outcomes (2)
Overall survival
60 months
Safety: Incidence of adverse events
60 months
Study Arms (1)
Cohort
Eligibility Criteria
First-line treatment with Avastin
You may qualify if:
- Adult patients, \>/= the 18 years of age
- Previously untreated metastatic colorectal cancer
- Scheduled to start 1st line chemotherapeutic treatment
- ECOG performance status 0-1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Bucharest, 022328, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2011
First Posted
January 14, 2011
Study Start
April 1, 2010
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
September 15, 2016
Record last verified: 2016-09