Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02807181
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2016-05-13
Brief Title:
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Sponsor:
Sirtex Medical
Organization:
Sirtex Medical
Study Overview
Official Title:
Prospective Multicenter Randomized Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
Status:
COMPLETED
Status Verified Date:
2023-04
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:
SIRCCA
Brief Summary:
The study will evaluate the benefit of applying Selective Internal Radiation Therapy SIRT using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment cisplatin-gemcitabine or CIS-GEM in patients with unresectable intrahepatic cholangiocarcinoma Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT and half of the patients will be randomized to CIS-GEM alone
Detailed Description:
This clinical study is a prospective multicenter randomized controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine CIS-GEM chemotherapy vs CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma
Randomized patients will be followed until death withdrawal of consent or until end of study
Randomized patients will be followed until death withdrawal of consent or until end of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None