Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer
- Determine the objective tumor response rate in patients with stage III or IV colorectal
adenocarcinoma treated with neoadjuvant radiotherapy and capecitabine.
- Determine the tolerance profile of this regimen in these patients.
- Determine the rate of preservation of functional integrity of the anal sphincter in
patients treated with this regimen.
- Compare the conversion rate from the effects of mutilating surgery vs surgery with
sphincter preservation in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily and undergo concurrent radiotherapy 5 days a
week on weeks 1-5. Patients undergo surgery on week 6.
Patients are followed every 4 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 10 months.
Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate
Olivier Dupuis, MD
Centre Jean Bernard
United States: Federal Government