Clinical trial NCT01775644: An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)
Official title: Avastin ® First Line and Where Applicable Beyond First Progression With Metastatic Colorectal Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-01-25
Enrollment: 3003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with metastatic 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.


Eligibility criteria: 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

Primary outcomes:
measure: Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST)
timeFrame: Baseline up to 5 years
Secondary outcomes:
measure: Percentage of Participants by Prognostic Factors
timeFrame: Baseline up to 5 years
measure: Percentage of Participants by Carcinoembryonic Antigen Tumor Marker
timeFrame: Baseline
measure: Percentage of Participants by Cancer Antigen 19-9 Tumor Marker
timeFrame: Baseline
measure: Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline
measure: Percentage of Participants by Comorbidity Index as per Carlson Method
timeFrame: Baseline
measure: Percentage of Participants by RAS Mutation Status
timeFrame: Baseline
measure: Percentage of Participants by Cancer Metastasation Status
timeFrame: Baseline
measure: Percentage of Participants According to Previous Treatment Regimen of Bevacizumab
timeFrame: Baseline
measure: Progression-Free Survival as Assessed by RECIST (Overall)
timeFrame: Baseline up to 5 years
measure: Overall Survival in Daily Routine Practice
timeFrame: Baseline up to 5 years
measure: Overall Survival in Defined Participant Subgroups in Daily Routine Practice
timeFrame: Baseline up to 5 years
measure: Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST
timeFrame: Baseline up to 5 years
measure: Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice
timeFrame: Baseline up to 5 years
measure: Number of Participants With Adverse Event
timeFrame: Baseline up to 5 years
measure: Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups
timeFrame: Baseline up to 5 years
measure: Total Cumulative Therapy Dose of Bevacizumab
timeFrame: Baseline up to 5 years
measure: Percentage of Participants With Treatment Success
timeFrame: Baseline up to 5 years
measure: Percentage of Participants With Resection
timeFrame: Baseline up to 5 years
measure: Number of Physicians Satisfied With Treatment
timeFrame: Baseline up to 5 years
measure: Percentage of Participants Without Resection by Reason
timeFrame: Baseline up to 5 years
measure: Percentage of Participants With Follow-Up therapy
timeFrame: Baseline up to 5 years
measure: Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST
timeFrame: Baseline up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: