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

NCT00796718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2016-08-25

Study results available
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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

Interventions

RADIATION

Standard radiotherapy

Administered as prescribed according to normal clinical practice.

DRUG

Capecitabine [Xeloda]

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Slovakia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796718 on ClinicalTrials.gov