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

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ClinicalTrials.gov Identifier: NCT01696695
Recruitment Status : Completed
First Posted : October 1, 2012
Results First Posted : November 9, 2016
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date September 27, 2012
First Posted Date October 1, 2012
Results First Submitted Date September 22, 2016
Results First Posted Date November 9, 2016
Last Update Posted Date March 23, 2017
Study Start Date July 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: September 27, 2012)
Progression-free survival with different Xeloda-based chemotherapy regimens [ Time Frame: approximately 4 years ]
Change History Complete list of historical versions of study NCT01696695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 22, 2016)
  • 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.
  • 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.
  • 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.
  • Mean Duration of Capecitabine Therapy [ Time Frame: Baseline up to 1254 days ]
  • Percentage of Participants With Dose Modification of Capecitabine [ Time Frame: Baseline up to 1254 days ]
Original Secondary Outcome Measures
 (submitted: September 27, 2012)
  • Objective response rate (complete response + partial response) [ Time Frame: approximately 4 years ]
  • Clinical benefit rate (complete response + partial response + stable disease) [ Time Frame: approximately 4 years ]
  • Metastasectomy rate [ Time Frame: approximately 4 years ]
  • Mean duration of Xeloda treatment [ Time Frame: approximately 4 years ]
  • Dose modification rate for Xeloda [ Time Frame: approximately 4 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer
Official Title Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.
Condition Colorectal Cancer
Intervention
  • Drug: Capecitabine
    First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics
    Other Name: Xeloda
  • Drug: Chemotherapy
    First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.
Study Groups/Cohorts Metastatic Colorectal Carcinoma (mCRC) Participants
Newly diagnosed mCRC participants, who will receive first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, will be observed. The choice of therapy is based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also do not specify any treatment regimen.
Interventions:
  • Drug: Capecitabine
  • Drug: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 31, 2015)
882
Original Estimated Enrollment
 (submitted: September 27, 2012)
500
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT01696695
Other Study ID Numbers ML27791
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2017