drugset / Trial / NCT00421824

Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

NCT00421824 ↗

Phase 2 Completed 108 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary: * To assess complete pathological response rate of both strategies. Secondary: * Safety profile * To assess downstaging rate of both strategies. * To compare relative dose intensity of oxaliplatin and capecitabine of both strategies * To compare time to progression and overall survival of both strategies.

Timeline

Start
2006-05
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 2000 unknown —
Subject Oxaliplatin Small molecule 130 unknown —

Indications