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)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01277120

Enrollment

174

Registered

2011-01-14

Start date

2010-04-30

Completion date

2016-04-30

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Correlation of the time from the start of chemotherapy to the start of Avastin treatment with progression-free survival	60 months

Secondary

Measure	Time frame
Overall survival	60 months
Safety: Incidence of adverse events	60 months

Countries

Romania

Outcome results