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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01775644

Enrollment

3003

Registered

2013-01-25

Start date

2012-12-14

Completion date

2019-05-10

Last updated

2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief 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.

Interventions

DRUGBevacizumab

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame
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
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 Cancer Metastasation Status	Baseline
Percentage of Participants by RAS Mutation Status	Baseline
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
Percentage of Participants by Comorbidity Index as per Carlson Method	Baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026