Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery (NCT00039078)

Study summary

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 the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.
Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.
Determine the toxic effects and adverse experiences associated with this therapy in these patients.
Determine the survival time of patients treated with this therapy.
Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.
Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.
Assess the quality of life of patients treated with this therapy.

OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.

Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.

Conditions studied

Liver Cancer

Browse trials for

Liver Neoplasms 1,391

Keywords

localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

Browse Liver Neoplasms studies →

Lead sponsor

This is the only study on the registry with Allan Tsung as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 120 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

DISEASE CHARACTERISTICS:

Confirmed diagnosis of hepatocellular carcinoma (HCC)
- Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level
No significant extrahepatic disease that may represent an imminent life-threatening outcome
No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
No hepatic dysfunction
Bilirubin ≤ 2.0 mg/dL
No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization
No pulmonary insufficiency
No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow
No contraindications to angiography
No contraindications to selective visceral catheterization
No other condition or cormorbidity that would preclude study treatment
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 30 days after study

PRIOR CONCURRENT THERAPY:

At least 1 month since prior chemotherapy, radiotherapy, or surgery
No other concurrent investigational agents or anticancer therapy for HCC

Study design

Phase: Phase 2
Primary purpose: Treatment
Enrollment: 0 participants (actual)

Interventions

Radiationyttrium Y 90 glass microspheres

What researchers measure

Primary outcomes

Response to treatment
Survival time from treatment
Adverse experiences

Study locations

1 site

UPMC Liver Cancer Center
Pittsburgh, Pennsylvania 15213, United States

References and documents

Publications

Goin JE, Salem R, Carr BI, Dancey JE, Soulen MC, Geschwind JF, Goin K, Van Buskirk M, Thurston K. Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: a risk-stratification analysis. J Vasc Interv Radiol. 2005 Feb;16(2 Pt 1):195-203. doi: 10.1097/01.RVI.0000142602.79459.90. PubMed 15713920 ↗
Geschwind JF, Salem R, Carr BI, Soulen MC, Thurston KG, Goin KA, Van Buskirk M, Roberts CA, Goin JE. Yttrium-90 microspheres for the treatment of hepatocellular carcinoma. Gastroenterology. 2004 Nov;127(5 Suppl 1):S194-205. doi: 10.1053/j.gastro.2004.09.034. PubMed 15508085 ↗
Salem R, Thurston KG, Carr BI, Goin JE, Geschwind JF. Yttrium-90 microspheres: radiation therapy for unresectable liver cancer. J Vasc Interv Radiol. 2002 Sep;13(9 Pt 2):S223-9. doi: 10.1016/s1051-0443(07)61790-4. PubMed 12354840 ↗
Carr BI. Hepatic arterial 90Yttrium glass microspheres (Therasphere) for unresectable hepatocellular carcinoma: interim safety and survival data on 65 patients. Liver Transpl. 2004 Feb;10(2 Suppl 1):S107-10. doi: 10.1002/lt.20036. PubMed 14762849 ↗
Carr BI, Sheetz M, Brown M, et al.: Hepatic arterial 90yttrium-labeled glass microspheres (Therasphere) as treatment for unresectable HCC in forty three patients. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-553, 2002.
Carr BI, Brown M, France M, et al.: 90 yttrium labeled glass microspheres in the treatment of hepatocellular carcinoma: initial US experience. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-2346, 2001.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00039078
Lead sponsor: Allan Tsung
Responsible party: Allan Tsung (Associate Professor, University of Pittsburgh) — Sponsor-investigator
First posted: Jan 27, 2003
Start date: Aug 2000
Primary completion: Aug 2000
Completion: Aug 2000
Last update: Jun 26, 2017

Study contacts

T. Clark Gamblin, MD

study chair · UPMC Cancer Center at UPMC Presbyterian

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery