Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 3:43 AM
Study NCT ID:
NCT00844233
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2009-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Chemoembolisation Using Irinotecan Bead Prior to Surgery in Metastatic Colorectal Cancer
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARAGON-II
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: