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

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02542436
• Other study ID #: ML29965
• Status: Withdrawn
• Phase: N/A
• First received: September 2, 2015
• Last updated: September 11, 2017
• Start date: September 1, 2015
• Est. completion date: December 31, 2015

Study information

• Verified date: September 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• No intervention
No intervention administered in this study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		From date of metastatic colorectal cancer diagnosis to date of death up to 3 years
Secondary	Response Rate (RR)		From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Secondary	Progression Free Survival (PFS)		From date of metastatic colorectal cancer diagnosis to end of study up to 3 years
Secondary	Percentage of Participants with Adverse Events of Special Interest		From date of metastatic colorectal cancer diagnosis to end of study up to 3 years