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Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00530010
Recruitment Status : Recruiting
First Posted : September 17, 2007
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

September 13, 2007
September 17, 2007
June 4, 2018
December 2004
January 2020   (Final data collection date for primary outcome measure)
Proportion of patients completing scheduled treatment plan [ Time Frame: At point that patient discontinues treatment for whatever reason. ]
  • Proportion of patients completing scheduled treatment plan
  • Response
  • Survival time
  • Adverse experiences
Complete list of historical versions of study NCT00530010 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.

OBJECTIVES:

  • Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection.
  • Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres (TheraSphere®) treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study treatment, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with unresectable cancer primarily in the liver with the liver being the only site of disease or the dominant site of disease
Liver Cancer
Radiation: yttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150 Gy (8,000-15,000 rad). Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart.
Not Provided
Salem R, Lewandowski RJ, Mulcahy MF, Riaz A, Ryu RK, Ibrahim S, Atassi B, Baker T, Gates V, Miller FH, Sato KT, Wang E, Gupta R, Benson AB, Newman SB, Omary RA, Abecassis M, Kulik L. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology. 2010 Jan;138(1):52-64. doi: 10.1053/j.gastro.2009.09.006. Epub 2009 Sep 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
250
January 2021
January 2020   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of intrahepatic carcinoma

    • Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP
  • Unresectable disease
  • No portal hypertension with portal venous shunt away from the liver
  • No significant extrahepatic disease representing an imminent life-threatening outcome
  • No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following:

    • First yttrium Y 90 glass microspheres (TheraSphere®) administration
    • Cumulative delivery of radiation to the lungs over multiple treatments

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • Absolute granulocyte count ≥ 1,500/μL
  • Platelet count > 25,000/μL
  • Serum creatinine < 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)
  • Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Any of the following contraindications to angiography and selective visceral catheterization:

    • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques
    • Bleeding diathesis, not correctable by usual forms of therapy
    • Severe peripheral vascular disease that would preclude catheterization
  • Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
  • Severe liver dysfunction or pulmonary insufficiency
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior and no other concurrent anticancer therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
United States
 
 
NCT00530010
NU 1365-001
P30CA060553 ( U.S. NIH Grant/Contract )
NU-1365-001
Yes
Not Provided
Not Provided
Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Riad Salem, MD Robert H. Lurie Cancer Center
Northwestern University
June 2018