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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

Rectal Neoplasms Clinical Trial

Official title:
Phase II Randomized Trial 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00421824
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date May 2006
Completion date November 2010
View Details
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