drugset / Trial / NCT00174616

CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision

NCT00174616 ↗

Phase 2 Completed 87 enrolled Sanofi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2003-07
Primary completion
2007-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 825 mg/m2 Oral
Subject Oxaliplatin Small molecule 50 mg/m2 Intravenous

Indications