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

NCT ID: NCT02542436

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type OTHER

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.

No intervention

Intervention Type OTHER

No intervention administered in this study

Interventions

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No intervention

No intervention administered in this study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Other Identifiers

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ML29965

Identifier Type: -

Identifier Source: org_study_id

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