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

Withdrawn

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: No intervention

• Registration Number: NCT02542436
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From date of metastatic colorectal cancer diagnosis to date of death up to 3 years

Secondary Outcome Measures

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