An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)

Avastin ® First Line and Where Applicable Beyond First Progression With Metastatic Colorectal Carcinoma

This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Bevacizumab

• Study Type: Observational
• Enrollment (Actual): 3003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with metastatic colorectal cancer

Description

Inclusion Criteria:

• Participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

• Contraindications for bevacizumab according to SmPC

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Metastatic Colorectal Cancer Participants; Administration of treatment will be as used in normal daily routine under local labelling in 4 subgroups- participants with liver and/or lung metastases, potentially resectable after a response to a systemic therapy and clinically operable; participants with tumor related symptoms, risks for complications or fast progression for whom quick proliferation control is needed; "asymptomatic" participants (indolent tumor) without the option of a metastases resection (no pressure for remission) for whom the aim of the therapy is proliferation control and participants without classification.

Drug: Bevacizumab; Administration of treatment will be as used in normal daily routine under local labeling.; Other Names: Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST)	Baseline up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants by Prognostic Factors	Baseline up to 5 years
Percentage of Participants by Carcinoembryonic Antigen Tumor Marker	Baseline
Percentage of Participants by Cancer Antigen 19-9 Tumor Marker	Baseline
Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status	Baseline
Percentage of Participants by Comorbidity Index as per Carlson Method	Baseline
Percentage of Participants by RAS Mutation Status	Baseline
Percentage of Participants by Cancer Metastasation Status	Baseline
Percentage of Participants According to Previous Treatment Regimen of Bevacizumab	Baseline
Progression-Free Survival as Assessed by RECIST (Overall)	Baseline up to 5 years
Overall Survival in Daily Routine Practice	Baseline up to 5 years
Overall Survival in Defined Participant Subgroups in Daily Routine Practice	Baseline up to 5 years
Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST	Baseline up to 5 years
Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice	Baseline up to 5 years
Number of Participants With Adverse Event	Baseline up to 5 years
Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups	Baseline up to 5 years
Total Cumulative Therapy Dose of Bevacizumab	Baseline up to 5 years
Percentage of Participants With Treatment Success	Baseline up to 5 years
Percentage of Participants With Resection	Baseline up to 5 years
Number of Physicians Satisfied With Treatment	Baseline up to 5 years
Percentage of Participants Without Resection by Reason	Baseline up to 5 years
Percentage of Participants With Follow-Up therapy	Baseline up to 5 years
Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST	Baseline up to 5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2012
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: ML28120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No