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

2014-07-24 14:14:20 | BioPortfolio

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.

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

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Metastatic Colorectal Cancer

Intervention

Irinotecan Bead

Location

Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke
United Kingdom

Status

Recruiting

Source

Biocompatibles UK Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:14:20-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.

Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).

Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.

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