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Completed

NCT Number: NCT01696695

An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer

This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.

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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

Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp., Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label

Exclusion criteria

  • History of serious or unexpected reaction to fluoropyrimidine therapy
  • Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
  • Known dihydropyrimidine dehydrogenase deficiency
  • Pregnancy or lactation
  • Inadequate bone marrow, hepatic or renal function
  • Treatment with sorivudine or its chemical analogues (for example, brivudine)
  • If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used

Treatment and study plan

Capecitabine

Drug

First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics

Other names: Xeloda

Chemotherapy

Drug

First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.

Primary outcomes

  1. Median Progression-free Survival (PFS)

    Time frame: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254

    PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.

  2. PFS by Therapeutic Regimens

    Time frame: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254

    PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.

Secondary outcomes

  1. Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1

    Time frame: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254

    Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

  2. Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1

    Time frame: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254

    Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions.

  3. Percentage of Participants Who Underwent Metastasectomy

    Time frame: Baseline up to 1254 days

    Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.

  4. Mean Duration of Capecitabine Therapy

    Time frame: Baseline up to 1254 days

  5. Percentage of Participants With Dose Modification of Capecitabine

    Time frame: Baseline up to 1254 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)

Acronym: AXEL

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 1, 2012
Registry last updated
Mar 23, 2017

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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