Back to resultsYttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases
Primary Purpose
Colorectal Neoplasms, Neuroendocrine Tumors, Cholangiocarcinoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Liver metastases
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy with liver dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
- The cancer is unresectable.
- All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Concurrent therapy with octreotide is permitted, when appropriate.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Age 18 years or older.
- Able to understand informed consent.
Exclusion Criteria:
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
- single TheraSphere administration; or
- cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
- Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition.
- Previous radiation therapy to the lungs and/or to the upper abdomen
- Pregnancy
- Symptomatic lung disease.
- Significant extrahepatic disease representing an imminent life-threatening outcome.
- Active uncontrolled infection
Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
- Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
- Serum bilirubin greater than 2 mg/dl
- Infiltrative tumor on imaging
- Tumor volume greater than 70% of liver volume
- Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yttrium-90 liver radioembolization
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.
Secondary Outcome Measures
Radiographic Response
Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.
Full Information
NCT ID
NCT01290536
First Posted
February 1, 2011
Last Updated
February 14, 2019
Sponsor
Nicholas Fidelman, MD
1. Study Identification
Unique Protocol Identification Number
NCT01290536
Brief Title
Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases
Official Title
Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Metastatic Liver Disease From Primary Colorectal, Neuroendocrine, Cholangiocarcinoma, Melanoma, and Breast Cancers Refractory to Chemotherapy: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicholas Fidelman, MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Neuroendocrine Tumors, Cholangiocarcinoma, Melanoma, Breast Cancer
Keywords
Liver metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yttrium-90 liver radioembolization
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)
Intervention Description
Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radiographic Response
Description
Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy with liver dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
The cancer is unresectable.
All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Concurrent therapy with octreotide is permitted, when appropriate.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Age 18 years or older.
Able to understand informed consent.
Exclusion Criteria:
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
single TheraSphere administration; or
cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition.
Previous radiation therapy to the lungs and/or to the upper abdomen
Pregnancy
Symptomatic lung disease.
Significant extrahepatic disease representing an imminent life-threatening outcome.
Active uncontrolled infection
Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
Serum bilirubin greater than 2 mg/dl
Infiltrative tumor on imaging
Tumor volume greater than 70% of liver volume
Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL
12. IPD Sharing Statement
Learn more about this trial
Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases
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