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| Sponsor: | Biocompatibles UK Ltd |
|---|---|
| Information provided by (Responsible Party): | Biocompatibles UK Ltd |
| ClinicalTrials.gov Identifier: | NCT00844233 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Device: Irinotecan Bead |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer |
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | October 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Irinotecan Bead
|
Device: Irinotecan Bead
Irinotecan eluting bead
Other Name: Irinotecan Bead, PARAGON Bead
|
The Primary Endpoint of this study is Tumour resectability at surgery. Secondary Endpoints:
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Absence of:
Adequate organ function as measured by:
Exclusion criteria
Contraindications to irinotecan:
Any contraindication for hepatic embolisation procedures:
Contacts and Locations| Austria | |
| Medical University Vienna, AKH | |
| Vienna, Austria, 1090 | |
| France | |
| Centre Hépato-Biliaire, Hôpital Paul Brousse | |
| Villejuif, France, 94804 | |
| United Kingdom | |
| Basingstoke and North Hampshire NHS Foundation Trust | |
| Basingstoke, United Kingdom, RG24 9NA | |
| University Hospital Aintree | |
| Liverpool, United Kingdom, L9 7AL | |
| North Manchester General Hospital | |
| Manchester, United Kingdom, M8 5RB | |
| Principal Investigator: | Graeme Poston, MB, MS, FRCS | Consultant General Surgeon |
More Information
| Responsible Party: | Biocompatibles UK Ltd |
| ClinicalTrials.gov Identifier: | NCT00844233 History of Changes |
| Other Study ID Numbers: | CA1016 |
| Study First Received: | February 9, 2009 |
| Last Updated: | September 28, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Spain: Agencia Española de Medicamentos y Productos Sanitarios |
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |