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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.


Phase 4
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

SAEs, AEs, laboratory parameters.

Outcome Time Frame:

Week 24

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Russia: Ministry of Health

Study ID:

ML20592

NCT ID:

NCT00502671

Start Date:

July 2007

Completion Date:

November 2012

Related Keywords:

  • Colorectal Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

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