NCT02071069

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Tianshu Liu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Incurable Colorectal Cancer
• RAS-wild-type

Interventions

Type	Name	Description
DRUG	Cetuximab	400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks
DRUG	irinotecan	180 mg/m2 IV every 2 weeks
DRUG	fluorouracil	400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2014-02-25
• Last updated: 2015-11-18

Locations

1 site across 1 country: China