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)

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01277120

First received: January 13, 2011

Last updated: September 14, 2016

Last verified: September 2016

History of Changes

Purpose

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
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:

MedlinePlus related topics: Colorectal Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

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:	174
Study Start Date:	April 2010
Study Completion Date:	April 2016
Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cohort

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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


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:	September 14, 2016
Health Authority:	Romania: Ministry of Health

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

ClinicalTrials.gov processed this record on September 30, 2016

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