A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer
To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.
Drug: Oxaliplatin, Capecitabine
Procedure: Pre operative radiotherapy
Procedure: Surgical Resection
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.|
- Pathological complete response rate.
- Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.
- Progression-free survival
- Treatment related toxicity
- Overall survival
- Radiological response rate
- Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan
- Surgical complications
- Bowel function and quality of life
|Study Start Date:||November 2001|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220051
|Principal Investigator:||D Cunningham||Royal Marsden NHS Foundation Trust|