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TerminatedNCT01276405Updated Nov 2, 2016

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

An observational study in Colorectal Cancer, sponsored by Hoffmann-La Roche. Terminated at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
123
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 123 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with colon cancer stage III (Duke C) on Xeloda monotherapy

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

Exclusion Criteria:

  • Contraindications for Xeloda
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
123 participants (actual)

Groups and cohorts

  • Cohort
06

What researchers measure

Primary outcomes

  1. Disease-free survival

    Time frame: 3 years

Secondary outcomes

  1. Safety (Incidence of adverse events)

    Time frame: 3 years

07

Study locations

1 site
  • Bucharest, 022 328, Romania
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01276405
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jan 13, 2011
Start date
Mar 2010
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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