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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.
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
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Metastatic Colorectal Cancer
Basingstoke and North Hampshire NHS Foundation Trust
Biocompatibles UK Ltd
Published on BioPortfolio: 2014-07-24T14:14:20-0400
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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).
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