Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer

Incurable Colorectal Cancer Clinical Trial

Official title: Efficacy and Tolerance of Cetuximab Combined With Irinotecan or Fluorouracil as Maintenance Therapy in Patients With RAS-wild-type Incurable Advanced Colorectal Cancer （Confirm Study）

Status Recruiting

Clinical Trial Summary

1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.

2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.

This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Incurable Colorectal Cancer
• RAS-wild-type

• NCT number: NCT02071069
• Study type: Interventional
• Source: Shanghai Zhongshan Hospital
• Contact: Tianshu Liu, Doctor
• Phone: +861368 1973 996
• Email: liu.tianshu@zs-hospital.sh.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2013
• Completion date: July 2016