AXEL Study: An Observational Study of First-Line Xeloda (Capecitabine) Based Chemotherapy With or Without Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696695
• Other study ID #: ML27791
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: August 1, 2016
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Instutute of Pharmacy
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the efficacy and safety of different Xeloda (capecitabine) based chemotherapies, alone or in combination with Avastin (bevacizumab), in first line in patients with metastatic colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with newly diagnosed metastatic colorectal cancer who have started first-line Xeloda-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 (e.g. brivudine)

• If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival with different Xeloda-based chemotherapy regimens		approximately 4 years	No
Secondary	Objective response rate (complete response + partial response)		approximately 4 years	No
Secondary	Clinical benefit rate (complete response + partial response + stable disease)		approximately 4 years	No
Secondary	Metastasectomy rate		approximately 4 years	No
Secondary	Mean duration of Xeloda treatment		approximately 4 years	No
Secondary	Dose modification rate for Xeloda		approximately 4 years	No
Secondary	Safety: Incidence of adverse events		approximately 4 years	No