NCT01237665

IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer

A Phase II Trial of Neoadjuvant IXO Regimen (Irinotecan, Capecitabine [Xeloda], Oxaliplatin) Followed by Combined Modality Capecitabine and Radiation for Locally Resectable Advanced Rectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective open label single-arm, single-institution phase II clinical trial to test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine \[Xeloda\], Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	IXO regimen	IXO regimen is administered as following: irinotecan 160 mg/m2 i.v. (over 60-90 minutes) with oxaliplatin 100 mg/m2 i.v. (over 120 minutes) on day 1, followed by capecitabine 950 mg/m2 PO, b.i.d. on days 2-15, every 3 weeks. Each cycle of IXO lasts 21 days, with the subsequent cycle to start on day 22.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-12-01
• Completion: 2017-12-01
• First posted: 2010-11-09
• Last updated: 2012-10-15

Locations

1 site across 1 country: Canada