Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in Normal Clinical Use in the UK Population

September 11, 2017 updated by: Hoffmann-La Roche

An Observational Study to Investigate the Real World Effectiveness of Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in the UK

This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with metastatic colorectal cancer

Description

Inclusion Criteria:

  • Have been diagnosed with metastatic colorectal cancer (mCRC)
  • Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment
  • Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer
  • Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab
  • Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom
  • For Cohort 1 (post CDF funding availability): patients between 2010-2013 who received bevacizumab with first-line chemotherapy
  • For Cohort 2 (pre Cancer Drugs Fund [CDF] funding availability): patients propensity matched to cohort 1 between 2005-2008 who did not receive bevacizumab with first-line chemotherapy

Exclusion Criteria:

  • Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial
  • Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: bevacizumab
Participants with metastatic colorectal cancer between 2010-2013, who received bevacizumab (25 mg/ml concentrate for solution for infusion) with first-line chemotherapy.
Other: No intervention
No intervention administered in this study
Cohort 2: no bevacizumab
Participants with metastatic colorectal cancer between 2005-2008, who did not receive bevacizumab with first-line chemotherapy.
Other: No intervention
No intervention administered in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From date of metastatic colorectal cancer diagnosis to date of death up to 3 years
From date of metastatic colorectal cancer diagnosis to date of death up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response Rate (RR)
Time Frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Progression Free Survival (PFS)
Time Frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Percentage of Participants with Adverse Events of Special Interest
Time Frame: From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
From date of metastatic colorectal cancer diagnosis to end of study up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2015

Primary Completion (Anticipated)

December 31, 2015

Study Completion (Anticipated)

December 31, 2015

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29965

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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