An Observational Study of First-Line Bevacizumab (Avastin) With Fluoropyrimidine-Based Chemotherapy in Participants With Metastatic Colorectal Cancer

An Open-Label, Multicenter, Non-Interventional, Observational Study To Assess The Effect Of First Line Bevacizumab Treatment With Fluoropyrimidine-Based Chemotherapy (CTX) In Patients With Metastatic Colorectal Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01712347

Enrollment

351

Registered

2012-10-23

Start date

2012-10-11

Completion date

2016-07-01

Last updated

2018-07-31

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 multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.

Interventions

DRUGBevacizumab

Bevacizumab will be administered as per approved label.

DRUGChemotherapy

The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with histologically confirmed metastatic colorectal cancer who will receive bevacizumab in combination with first-line fluoropyrimidine-based chemotherapy

Exclusion criteria

* Participants not qualified for bevacizumab treatment according to the local label

Design outcomes

Primary

Measure	Time frame
Overall survival from the time of starting first-line therapy	Start of first line therapy until death (up to approximately 4 years)

Secondary

Measure	Time frame
Number of participants with adverse events	up to approximately 4 years
Progression-free survival from the time of starting first-line therapy, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria	Start of first line therapy until death (up to approximately 4 years)
Percentage of participants with best overall response, assessed according to RECIST v.1.1 criteria	Start of first line therapy until death (up to approximately 4 years)
Percentage of participants with liver resection	up to approximately 4 years

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026