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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- adult patients >=18 years of age;

- colon cancer;

- complete tumor resection.

Exclusion Criteria:

- prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the
currently treated 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

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Great Falls, Montana  59405
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Hackensack, New Jersey  07601
Albuquerque, New Mexico  87131-5636
Metairie, Louisiana  70006
Denver, Colorado  
Charlotte, North Carolina  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina  
Lebanon, New Hampshire  
Washington, District of Columbia  
Las Vegas, Nevada  89109
Salt Lake City, Utah  84112
Coeur D'alene, Idaho  83814