Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 17, 2007
Last updated: March 2, 2015
Last verified: March 2015

July 17, 2007
March 2, 2015
July 2007
March 2012   (final data collection date for primary outcome measure)
SAEs, AEs, laboratory parameters. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Serious adverse events, AEs, laboratory abnormalities.
Complete list of historical versions of study NCT00502671 on Archive Site
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A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.

This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Not Provided
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 of each 3 week cycle
Experimental: 1
Intervention: Drug: capecitabine [Xeloda]
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • colon cancer (Dukes stage C);
  • surgery, with no evidence of remaining tumor;
  • ECOG performance status of <=1.

Exclusion Criteria:

  • previous therapy for currently treated colon cancer;
  • any evidence of metastatic disease;
  • history of other malignancy within last 5 years;
  • clinically significant cardiac disease.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Russian Federation
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP