A Study of Xeloda (Capecitabine) Plus Radiotherapy in Patients With Locally Advanced Rectal Cancer

Colorectal Cancer Clinical Trial

Official title:

An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796718
• Other study ID #: ML21800
• Secondary ID: 2008-003980-38
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2008
• Last updated: May 4, 2016
• Start date: October 2008
• Est. completion date: August 2010

Study information

• Verified date: May 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in patients with locally advanced rectal cancer. Eligible patients will receive Xeloda 825mg/m2 po bid plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is < 3 months, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-80 years of age

• rectal cancer;

• planned surgery, and likely to benefit from pre=operative combined chemo-radiotherapy;

• ECOG performance status 0-2.

Exclusion Criteria:

• previous radiotherapy or chemotherapy for colorectal cancer;

• clinically significant cardiovascular disease;

• significant gastric or small intestine disease;

• serious uncontrolled active infection.

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Radiation:
• Standard radiotherapy
As prescribed

Drug:
• capecitabine [Xeloda]
825mg/m2 po bid for 5 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response		4 weeks after end of treatment	No
Secondary	Adverse events, laboratory parameters		Throughout study	No