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NCT01276405 Clinical Trial

An Observational Study of Xeloda (Capecitabine) Monotherapy in Patients With Colorectal Cancer (AXEL)

Colorectal Cancer Clinical Trial

Official title:
The Efficacy of Adjuvant Chemotherapy With Capecitabine (Xeloda) Monotherapy in Patients With Colon Cancer Stage III (Duke C) Considering the Histopathology of the Tumour (AXEL)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01276405
Other study ID # ML25174
Secondary ID
Status Terminated
Phase N/A
First received January 12, 2011
Last updated November 1, 2016
Start date March 2010
Est. completion date October 2015

Study information
Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Romania: National Medicine and Medical Devices Agency (NMMDA)
Study type Observational

Clinical Trial Summary

This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of disease-free survival in patients with colon cancer stage III (Duke C) after surgical resection. Data will be collected for 3 years.

Recruitment information / eligibility
Status Terminated
Enrollment 123
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients, over the age of 18 years

- Presence of colon adenocarcinoma

- Surgical resection for colon cancer stage III (Duke C)

- Prior adjuvant therapy with Xeloda monotherapy

Exclusion Criteria:

- Contraindications for Xeloda

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease-free survival 3 years No
Secondary Safety (Incidence of adverse events) 3 years No
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