NCT01552967

Efficacy and Safety Study of a Modified XELOX Regimen in First-Line Treatment of Metastatic Colorectal Adenocarcinoma

A Phase II Trial Evaluating a Modified Regimen of Oxaliplatin and Capecitabine in First-Line Treatment of Metastatic Colorectal Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, phase II study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and capecitabine on metastatic colorectal adenocarcinoma in the first-line therapy.

Detailed description

Primary endpoint: Overall Response Rate Secondary endpoint: Time to progression, overall survival, safety data

Conditions

• Colorectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Capecitabine	Oxaliplatin 85mg/m2 D1 and capecitabine 1g/m2 BID D1-D10, repeat every two weeks. Efficacy will be evaluated every three cycles.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• Completion: 2014-02-01
• First posted: 2012-03-13
• Last updated: 2012-03-28

Locations

1 site across 1 country: China