An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer.
Phase 2
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological complete response
Outcome Time Frame:
4 weeks after end of treatment
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Slovakia: State Institute for Drug Control
Study ID:
ML21800
NCT ID:
NCT00796718
Start Date:
October 2008
Completion Date:
August 2010
Related Keywords:
- Colorectal Cancer
- Rectal Neoplasms
- Colorectal Neoplasms
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