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OpenTrials
Completed

NCT Number: NCT01399190

An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).

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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

Primary location

Banská Bystrica, Slovakia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Metastatic colorectal cancer
  • Treatment in accordance with current Summary of Product Characteristics and local guidelines

Exclusion criteria

  • Contraindications according to current Summary of Product Characteristics and local guidelines

Treatment and study plan

Bevacizumab

Biological

Bevacizumab administered according to prescribing information and normal clinical practice.

Other names: Avastin®

Capecitabine

Biological

Capecitabine administered according to prescribing information and normal clinical practice.

Other names: Xeloda®

Oxaliplatin

Drug

Capecitabine administered according to prescribing information and normal clinical practice.

Other names: Eloxatin™

Primary outcomes

  1. Progression-free Survival

    Time frame: From randomization to progression or death during the study (up to approximately 30 months)

    Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.

Secondary outcomes

  1. Response Rate (Tumor Assessments According to RECIST)

    Time frame: Up to approximately 30 months

    Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR

  2. Percentage of Participants With Adverse Events

    Time frame: Up to approximately 30 months

    An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2011
Registry last updated
Sep 28, 2016

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.

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