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

Roche

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: Capecitabine; Drug: Chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01696695

ML27791

Details and patient eligibility

About

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.

Enrollment: 882 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

882 participants in 1 patient group

Metastatic Colorectal Carcinoma (mCRC) Participants

Description:

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.

Treatment:

Drug: Chemotherapy

Drug: Capecitabine