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

PHASE2CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Rectal Neoplasms
Interventions
DRUG

Oxaliplatin, capecitabine

OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery

DRUG

Oxaliplatin, capecitabine

XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.

Trial Locations (1)

Unknown

Sanofi-Aventis Administrative Office, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY