NCT00469963

Brief Summary

RATIONALE: Specialized internal radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

May 3, 2007

Last Update Submit

August 31, 2012

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinomalocalized unresectable adult primary liver cancerrecurrent adult primary liver canceradvanced adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor response

    All uni-dimensional measurable lesions (longest diameter \>20mm with conventional techniques and \>10mm with spiral CT scans) up to a maximum of five lesions per organ with a maximum of 10 lesions in total are used to determine response.

    up to 12 months

Secondary Outcomes (3)

  • Toxicity

    up to 3 months

  • Health-related quality of life

    prior to initial treatment.

  • Survival

    trial entry to death

Study Arms (1)

SIR-SPHERES

EXPERIMENTAL
Procedure: quality-of-life assessmentRadiation: yttrium Y 90 resin microspheres

Interventions

quality-of-life assessmentPROCEDURE

quality-of-life assessment

SIR-SPHERES
yttrium Y 90 resin microspheresRADIATION

radiation therapy

Also known as: radiation therapy
SIR-SPHERES

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hepatocellular carcinoma
  • Not amenable to surgical resection or immediate liver transplantation
  • Destaging of tumor prior to surgical resection or transplantation allowed
  • Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) ≥ 10 mm by contrasted CT scan
  • No equivocal, nonmeasurable, or nonevaluable liver cancer
  • No more than 75% replacement of normal liver by tumor
  • Cancer of the Liver Italian Program (CLIP) stage 1-3 disease
  • No extra-hepatic metastases as determined by CT scan or MRI

You may not qualify if:

  • Life expectancy ≥ 3 months
  • Karnofsky performance status 50-100%
  • Creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin ≥ 3 g/dL
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 65,000/mm³
  • INR ≤ 1.4
  • Hemoglobin \> 9 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No nonmalignant disease that would render the patient ineligible for treatment according to this protocol
  • No hepatic arterial anatomy that would prevent the administration of study drug into the liver
  • Less than 20% arteriovenous lung shunting on a technetium 99m-labeled macroaggregated albumin nuclear scan
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Steven G. Meranze, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

December 1, 2003

Primary Completion

October 1, 2006

Study Completion

April 1, 2007

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

US(1)