Status:

COMPLETED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

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 rec...

Eligibility Criteria

Inclusion

  • 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

  • previous radiotherapy or chemotherapy for colorectal cancer;
  • clinically significant cardiovascular disease;
  • significant gastric or small intestine disease;
  • serious uncontrolled active infection

Key Trial Info

Start Date :

October 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2010

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT00796718

Start Date

October 1 2008

End Date

August 1 2010

Last Update

August 25 2016

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Banská Bystrica, Slovakia, 975 17

2

Bratislava, Slovakia, 833 10