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

NCT02542436 | Withdrawn

• 1 other identifier: ML29965
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  From date of metastatic colorectal cancer diagnosis to date of death up to 3 years

Secondary Outcomes (3)

• Response Rate (RR)

  From date of metastatic colorectal cancer diagnosis to end of study up to 3 years

• 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

Study Arms (2)

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

Cohort 2: no bevacizumab

Participants with metastatic colorectal cancer between 2005-2008, who did not receive bevacizumab with first-line chemotherapy.

Other: No intervention

Interventions

No intervention OTHER

No intervention administered in this study

Cohort 1: bevacizumab; Cohort 2: no bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with metastatic colorectal cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 7, 2015
• Study Start: September 1, 2015
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: September 13, 2017

Record last verified: 2017-09