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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-01-12
• Last updated: 2011-01-04

Locations

1 site across 1 country: Spain