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

NCT ID: NCT00796718

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-08-31

Brief Summary

This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m^2 orally twice daily 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine

Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.

Group Type: EXPERIMENTAL

Standard radiotherapy

Intervention Type: RADIATION

Administered as prescribed according to normal clinical practice.

Capecitabine [Xeloda]

Intervention Type: DRUG

825 milligrams per meter square (mg/m\^2) orally twice daily for 5 weeks.

Interventions

Standard radiotherapy

Administered as prescribed according to normal clinical practice.

Intervention Type: RADIATION

Capecitabine [Xeloda]

825 milligrams per meter square (mg/m\^2) orally twice daily for 5 weeks.

Intervention Type: DRUG

Other Intervention Names

Xeloda®

Eligibility Criteria

Inclusion Criteria

• adult patients, 18-80 years of age;
• rectal cancer;
• planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;
• Eastern Cooperative Oncology Group (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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Banská Bystrica, , Slovakia

Bratislava, , Slovakia

Countries

Slovakia

Other Identifiers

2008-003980-38

Identifier Type: -

Identifier Source: secondary_id

ML21800

Identifier Type: -

Identifier Source: org_study_id