Skip to main content
OpenTrials
Completed

NCT Number: NCT01775644

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

Administration of treatment will be as used in normal daily routine under local labeling.

Other names: Avastin

Primary outcomes

  1. Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST)

    Time frame: Baseline up to 5 years

Secondary outcomes

  1. Percentage of Participants by Prognostic Factors

    Time frame: Baseline up to 5 years

  2. Percentage of Participants by Carcinoembryonic Antigen Tumor Marker

    Time frame: Baseline

  3. Percentage of Participants by Cancer Antigen 19-9 Tumor Marker

    Time frame: Baseline

  4. Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status

    Time frame: Baseline

  5. Percentage of Participants by Comorbidity Index as per Carlson Method

    Time frame: Baseline

  6. Percentage of Participants by RAS Mutation Status

    Time frame: Baseline

  7. Percentage of Participants by Cancer Metastasation Status

    Time frame: Baseline

  8. Percentage of Participants According to Previous Treatment Regimen of Bevacizumab

    Time frame: Baseline

  9. Progression-Free Survival as Assessed by RECIST (Overall)

    Time frame: Baseline up to 5 years

  10. Overall Survival in Daily Routine Practice

    Time frame: Baseline up to 5 years

  11. Overall Survival in Defined Participant Subgroups in Daily Routine Practice

    Time frame: Baseline up to 5 years

  12. Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST

    Time frame: Baseline up to 5 years

  13. Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice

    Time frame: Baseline up to 5 years

  14. Number of Participants With Adverse Event

    Time frame: Baseline up to 5 years

  15. Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups

    Time frame: Baseline up to 5 years

  16. Total Cumulative Therapy Dose of Bevacizumab

    Time frame: Baseline up to 5 years

  17. Percentage of Participants With Treatment Success

    Time frame: Baseline up to 5 years

  18. Percentage of Participants With Resection

    Time frame: Baseline up to 5 years

  19. Number of Physicians Satisfied With Treatment

    Time frame: Baseline up to 5 years

  20. Percentage of Participants Without Resection by Reason

    Time frame: Baseline up to 5 years

  21. Percentage of Participants With Follow-Up therapy

    Time frame: Baseline up to 5 years

  22. Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST

    Time frame: Baseline up to 5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2013
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.