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Completed

NCT Number: NCT01697462

An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)

This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.

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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

Belgrade, Serbia

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
  • Receiving Xeloda according to registered indication

Exclusion criteria

  • Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics

Treatment and study plan

Primary outcomes

  1. Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to end of study (up to 42 months)

    An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.

Secondary outcomes

  1. Percentage of Participants With Disease Progression

    Time frame: Baseline to progressive disease or death (up to 42 months)

    Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.

  2. Progression-Free Survival (PFS)

    Time frame: Baseline to progressive disease or death (up to 42 months)

    PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.

  3. Number of Participants With Hand-Foot Syndrome (HFS)

    Time frame: Baseline up to end of study (up to 42 months)

    HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 2, 2012
Registry last updated
Jan 26, 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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