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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: November 21, 2008
Last updated: May 4, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Colorectal Cancer
Radiation: Standard radiotherapy
Drug: capecitabine [Xeloda]
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pathological complete response [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Radiation: Standard radiotherapy
As prescribed
Drug: capecitabine [Xeloda]
825mg/m2 po bid for 5 weeks


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00796718

Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 833 10
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00796718     History of Changes
Other Study ID Numbers: ML21800  2008-003980-38 
Study First Received: November 21, 2008
Last Updated: May 4, 2016
Health Authority: Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 25, 2016