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CompletedNCT01290536Updated Mar 1, 2019Results posted

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

A Phase 2 interventional study of Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere) in Colorectal Neoplasms, Neuroendocrine Tumors and Cholangiocarcinoma, sponsored by Nicholas Fidelman, MD. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-01.

Sponsored by Nicholas Fidelman, MD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Colorectal Neoplasms
  • Neuroendocrine Tumors
  • Cholangiocarcinoma
  • Melanoma
  • Breast Cancer

Keywords

  • Liver metastases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Yttrium-90 liver radioembolization

    Device: Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)

Interventions

  • DeviceSelective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)

    Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months after treatment

06

Results

Posted Dec 22, 2014

Participant flow

Between May 2010 and October 2013, 42 adult patients with liver-dominant metastaticd colorectal or neuroendocrine cancer to the liver, or intrahepatic cholangiocarcinoma were enrolled in a prospective single-institution pilot study.

Participant flow — Overall Study
MilestoneYttrium-90 Radioembolization
Started42
Completed42
Not completed0

Outcome measures

PrimaryNumber 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.

Time frame:
6 months
Reported as:
Number · participants
Number of Participants With Adverse Events
participantsYttrium-90 Radioembolization
Number of Participants With Adverse Events42
SecondaryRadiographic 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.

Time frame:
6 months after treatment
Reported as:
Number · participants
Radiographic Response
participantsColorectal - Yttrium-90 RadioembolizationNeuroendocrine - Yttrium-90 RadioembolizationOther Tumors - Yttrium-90 Radioembolization
Complete Response (CR)000
Partial Response (PR)471
Stable Disease (SD)1246
Progressive Disease (PD)403

Adverse events

Collected over 6 months after treatment. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Yttrium-90 Liver Radioembolization—3/42 (7.1%)42/42 (100%)
Most frequent serious events
Most frequent serious events
EventYttrium-90 Liver Radioembolization
hospitalization for carcinoid crisisBlood and lymphatic system disorders1/11
VomitingGastrointestinal disorders1/42
gastric ulcerGastrointestinal disorders1/42
Most frequent other events
Showing 10 of 23
Most frequent other events
EventYttrium-90 Liver Radioembolization
FatigueGeneral disorders34/42
ASTMetabolism and nutrition disorders24/42
NauseaGeneral disorders20/42
Abdominal painGeneral disorders19/42
AnorexiaGastrointestinal disorders18/42
AlbuminemiaMetabolism and nutrition disorders15/42
ALTMetabolism and nutrition disorders14/42
BilirubinMetabolism and nutrition disorders9/42
VomitingGastrointestinal disorders8/42
SweatingGeneral disorders7/42

Baseline characteristics

per protocol

Age, Continuous
Age, Continuous(years)Yttrium-90 Radioembolization
Median61 (35 to 85)
Sex: Female, Male
Sex: Female, Male(Participants)Yttrium-90 Radioembolization
Female11
Male31
Region of Enrollment
Region of Enrollment(participants)Yttrium-90 Radioembolization
United States42
07

Study locations

No study locations are listed for this record.

08

Registry details

Key details

Study ID
NCT01290536
Lead sponsor
Nicholas Fidelman, MD
Responsible party
Nicholas Fidelman, MD (Principal Investigator, University of California, San Francisco) — Sponsor-investigator
First posted
Feb 7, 2011
Start date
May 2010
Primary completion
Oct 2013
Completion
Oct 2013
Results posted
Dec 22, 2014
Last update
Mar 1, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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