Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors

Phase 2

Completed

• Conditions: Liver Neoplasms
• Interventions: Device: TheraSphere, Yttrium-90 glass Microspheres

• Registration Number: NCT01177007
• Lead Sponsor: Yale University

Brief Summary

This study is an open label prospective trial of TheraSphere treatment for patients who have liver metastases who have failed or are intolerant to other systemic or liver directed therapies. Patients will be treated with TheraSphere at doses of 120 ± 10% Gy, and then followed for time to progression (TTP), safety, and overall survival.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Study Start: 2010-09
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2017-04-19
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-24
• Last Update Submitted: 2017-07-24
• Results First Posted: 2017-08-28
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TheraSphere	TheraSphere, Yttrium-90 glass Microspheres	-

Primary Outcome Measures

Name	Time	Method
Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria	Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.	This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.
Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria	2 years	Progression-free survival was defined as the time from the date of Y-90 radioembolization to date of disease progression or latest follow-up. PFS was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. RECIST and EASL criteria were used to assess progression with kappa value for intermethod agreement of treatment responses of 0.9.

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP) of the Treated Lesion(s) According to EASL Criteria	Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.	This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.
Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0	12 months	Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, at 4 weeks post treatment, and subsequent 3 month intervals.; Complete Response (CR): Disappearance of all lesions targeted by Y90 Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by Y90 Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by Y90 Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.
Tumor Response by the European Association for the Study of the Liver (EASL) Criteria	12 months	Efficacy as assessed by radiographic tumor response using EASL criteria at baseline up to 12 months post treatment.; Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions.
Overall Survival (OS)	Median follow-up time was 11.41 months (CI: 1.5-33.7)	Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as "open-ended". Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type.
Overall Survival (OS) Rate at 2 Years	Up to 2 years	Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as "open-ended". At the time of results reporting, this outcome was presented as "Up to 2 years". Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. 2-year OS rates were also stratified based on tumor burden.
Safety as Graded by CTCAE Version 3.0	12 months	Clinical and biochemical toxicity that were assessed as at least possibly related to treatment were recorded from the day of treatment until protocol exit or death. Toxicities were graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Mean Radiation Dose Delivered to Total Liver	24 hours	Therasphere dose calculation was performed using positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography (SPECT) imaging post-procedure to estimate the actual delivered dose of Theraspheres to the liver.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States