Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases

Phase 2

Completed

• Conditions: Breast Cancer; Melanoma; Colorectal Neoplasms; Neuroendocrine Tumors; Cholangiocarcinoma

• Registration Number: NCT01290536
• Lead Sponsor: Nicholas Fidelman, MD

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2014-05-10
• Results First Submitted QC: 2014-12-11
• Results First Posted: 2014-12-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	6 months	Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.

Secondary Outcome Measures

Name	Time	Method
Radiographic Response	6 months after treatment	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.