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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775644
• Other study ID #: ML28120
• Status: Completed
• Start date: December 14, 2012
• Est. completion date: May 10, 2019

Study information

• Verified date: November 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3003
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Bevacizumab
Administration of treatment will be as used in normal daily routine under local labeling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

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