Primary objective: * Pathological complete response (ypT0N0) rate Secondary objectives: * Histopathological R0 resection rate * Pathological downstaging (ypT0-T2N0) rate * One month surgical complication rate * Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes * Safety * Local and distant recurrence rates * Progression-free survival * Overall survival
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
87
* Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses * Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks * Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Sanofi-Aventis Administrative Office
Milan, Italy
MRI staging and TME surgery
Time frame: within 4 - 6 weeks after completion XELOX-RT
Measure safety - NCI-CTC version 2
Time frame: from baseline to end of study
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Sanofi-Aventis Administrative Office
Pe Gouda, Netherlands
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom