A Randomized, Open-label Study of the Effect of Intermittent Xeloda in Combination With Eloxatin, Versus Fluorouracil/Leucovorin, on Disease-free Survival in Patients Who Have Undergone Surgery for Colon Cancer.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free Survival (DFS) [Number of Events]

Outcome Description:

Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.

Outcome Time Frame:

Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO16968

NCT ID:

NCT00069121

Start Date:

January 2003

Completion Date:

January 2012

Related Keywords:

• Colorectal Cancer
• Colonic Neoplasms
• Colorectal Neoplasms