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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression-free survival with different Xeloda-based chemotherapy regimens

Outcome Time Frame:

approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Hungary: National Instutute of Pharmacy

Study ID:

ML27791

NCT ID:

NCT01696695

Start Date:

July 2011

Completion Date:

March 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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