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

NCT01775644 | Completed FDA Drug

• 1 other identifier: ML28120
• Study Type: observational
• Target: 3,003
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 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

Study Arms (1)

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

Interventions

Bevacizumab DRUG

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

Also known as: Avastin

Metastatic Colorectal Cancer Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with metastatic colorectal cancer

You may qualify if:

• 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)

You may not qualify if:

• Contraindications for bevacizumab according to SmPC

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 25, 2013
• Study Start: December 14, 2012
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: December 2, 2021

Record last verified: 2021-11