NCT00844233

Study of Chemoembolisation Using Irinotecan Bead Prior to Surgery in Metastatic Colorectal Cancer

A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of resectable liver metastases from colorectal cancer.

Detailed description

The Primary Endpoint of this study is Tumour resectability at surgery. Secondary Endpoints: 1. Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0) 2. Tumour response assessed by imaging (RECIST and necrosis) 3. Viable residual tumour assessed by pathological evaluation of resected liver tissue. 4. Recurrence (time and site) following resection 5. Correlation of tumour response by imaging and pathology

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Irinotecan Bead	Irinotecan eluting bead

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-09-01
• Completion: 2012-10-01
• First posted: 2009-02-16
• Last updated: 2021-07-21

Locations

5 sites across 3 countries: Austria, France, United Kingdom