A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

A Randomized, Open-label Study Comparing Adjuvant Chemotherapy With Xeloda, or 5-fluorouracil Plus Leucovorin, on Disease-free and Overall Survival in Patients Who Have Had Surgery for Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00009737
• Other study ID #: M66001
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2001
• Last updated: December 1, 2015
• Start date: November 1998
• Est. completion date: March 2008

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-FU 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3348
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients 18-75 years of age;

• histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.

Exclusion Criteria:

• previous chemotherapy

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• 5-FU
425mg/m2 iv daily from day 1 to day 5 every 28 days.
• Leucovorin
20mg/m2 iv daily from day 1 to day 5 every 28 days.
• capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 every 21 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Germany,  Israel,  Italy,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority in disease-free survival, overall survival, and relapse-free survival.		Event driven	No
Secondary	AEs, laboratory parameters, QoL.		Throughout study	No