The study planned to 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 were randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients were randomized to CIS-GEM alone.
This clinical study was 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 were to be followed until death, withdrawal of consent, or until end of study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Systemic chemotherapy
SIR-Spheres microspheres followed by systemic chemotherapy
Providence Health Care
Spokane, Washington, United States
Survival at 18 Months
Survival at 18 months is defined as the proportion of patients still alive 18 months from the date of randomization. The outcome was analyzed but the clinical database is not deemed to be reliable.
Time frame: 18 months following the date of randomization.
Liver-specific Progression Free Survival (PFS)
Liver-specific PFS was defined as the number of days between randomization and the date of first tumor progression in the liver. Diagnosis of tumor progression was to be made using RECIST 1.1.
Time frame: From date of randomization to the first documented date of progression in the liver or date of death from any cause, assessed up to 36 months..
Progression Free Survival (PFS) at Any Site
PFS was defined as the time interval between randomization and the date of tumor progression. Diagnosis of tumor progression was to be made using RECIST 1.1. The outcome was not analyzed due to unreliability of the clinical database.
Time frame: From date of randomization to the date of progression at any site until the first date of documented tumor progression at any site or date of death from any cause, assessed up to 36 months.
Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver
The outcome was not analyzed due to unreliability of the clinical database.
Time frame: From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months.
Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site
The outcome was not analyzed due to unreliability of the clinical database.
Time frame: From the date of first treatment until progression at any site, assessed up to 36 months.
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Macquarie University Hospital
North Ryde, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hopital Beaujon
Clichy, France
CHU Dijon
Dijon, France
CHU de Grenoble
Grenoble, France
CHU Lyon - Hospital de la Croix-Rousse
Lyon, France
Institut Paoli Calmettes
Marseille, France
CHU Montpellier
Montpellier, France
...and 13 more locations
Overall Survival
The outcome was not analyzed due to unreliability of the clinical database.
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.
Liver Surgical Resection and Ablation Rate
To assess the number of patients in each arm who are downstaged by protocol therapy and can proceed to liver resection or ablation. The specific assessments will be the classification of resection as R0, R1 or R2, the presence of viable tumor or fibrosis, and the nearest resection margin. The outcome was not analyzed due to unreliability of the clinical database.
Time frame: 18 months following the date of randomization.
Incidence of Adverse Events (Safety and Tolerability)
Adverse events (AEs) as assessed by CTCAE v. 4.0. Summaries of non-serious AEs (clinical database, MedDRA 20.1) and serious adverse events (SAEs; pharmacovigilance database, MedDRA 25.1) are provided for information only in the 'Adverse Events' section - the data are deemed unreliable.
Time frame: Informed consent until 28 days post last dose of protocol chemotherapy.