Study of Chemoembolisation Using Irinotecan Bead Prior to Surgery in Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Device: Irinotecan Bead
- Registration Number
- NCT00844233
- Lead Sponsor
- Boston Scientific Corporation
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Irinotecan Bead Irinotecan Bead
- Primary Outcome Measures
Name Time Method Tumour resectability at surgery 1 month
- Secondary Outcome Measures
Name Time Method Safety assessed by SAE and AE monitoring (NCI CTCAE v3.0) 1 month
Trial Locations
- Locations (5)
Medical University Vienna, AKH
🇦🇹Vienna, Austria
Centre Hépato-Biliaire, Hôpital Paul Brousse
🇫🇷Villejuif, France
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, United Kingdom
University Hospital Aintree
🇬🇧Liverpool, United Kingdom
North Manchester General Hospital
🇬🇧Manchester, United Kingdom
Medical University Vienna, AKH🇦🇹Vienna, Austria