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A Prospectively Randomized Controlled Clinical Trial Comparing TheraSphere With Cisplatin-Based TACE (Trans Arterial Chemo Embolization) in the Management of Advanced Stage, Unresectable Hepatocellular Carcinoma (HCC)

Phase 3
18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

A Prospectively Randomized Controlled Clinical Trial Comparing TheraSphere With Cisplatin-Based TACE (Trans Arterial Chemo Embolization) in the Management of Advanced Stage, Unresectable Hepatocellular Carcinoma (HCC)



- Compare time to disease progression in patients with unresectable advanced
hepatocellular carcinoma treated with cisplatin-based trans-arterial chemoembolization
vs hepatic intra-arterial yttrium Y 90 glass microspheres (TheraSphere®).

- Compare the health-related quality of life of patients treated with these regimens.

- Compare the safety of these regimens in these patients.


- Compare survival of patients treated with these regimens.

- Compare tumor response by CT scan in patients treated with these regimens.

- Compare treatment-related costs, in terms of cost of therapy and number of
hospitalization days, in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to extent of tumor in
the liver (< 50% vs ≥ 50%) and presence of portal hypertension (yes vs no). Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo trans-arterial chemoembolization comprising intra-arterial (IA)
infusion of cisplatin over 30-60 minutes followed by embolization of the hepatic artery
(that brings blood to the tumor) on day 1. Treatment repeats every 8-10 weeks in the
absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive yttrium Y 90 glass microspheres (TheraSphere®) IA on day 1.
Beginning 60 days after the first TheraSphere® treatment, patients may receive
additional treatment with TheraSphere® only if follow-up CT scans show progressive

Quality of life is assessed at baseline and then every 3 months thereafter.

After the completion of study treatment, patients are followed at 30 days and then every 2
months for 2 years.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this

Inclusion Criteria


- Diagnosis of 1 of the following:

- Histologically or cytologically confirmed hepatocellular carcinoma (HCC)

- Confined to the liver

- Vascular liver mass in the presence of cirrhosis

- Alpha-fetoprotein level > 500 ng/mL

- Measurable disease

- At least 1 unidimensionally measurable lesion > 20 mm by spiral CT scan

- Unresectable disease, due to tumor size or extent or presence of cirrhosis

- No metastatic disease, including brain metastases

- Locoregional lymph node metastases allowed

- No evidence of potential delivery of > 16.5 miCi (30 Gy absorbed dose) of
radiotherapy to the lungs either during the first administration of yttrium Y 90
glass microspheres (TheraSphere®) or on cumulative delivery of radiation to the lungs
over multiple treatments*

- No evidence of detectable technetium Tc 99m macroaggregated albumin (Tc-99m MAA) flow
to the stomach or duodenum after application of established angiographic techniques
to stop the flow* NOTE: *For patients randomized to the TheraSphere® arm only



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- More than 12 weeks


- WBC > 2,500/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Platelet count > 60,000/mm^3

- No bleeding diathesis not correctable by usual forms of therapy


- See Disease Characteristics

- Bilirubin < 2.0 mg/dL

- AST and/or ALT ≤ 5 times upper limit of normal

- Hepatitis allowed

- No portal hypertension with hepatofugal flow


- Creatinine < 2.5 mg/dL


- No symptomatic congestive heart failure

- No severe peripheral vascular disease that would preclude catheterization


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double barrier or hormonal contraception during
and for at least 30 days after completion of study treatment

- No ongoing or active infection

- No other uncontrolled illness

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy

- Not specified


- No more than 1 prior systemic chemotherapy for HCC

- More than 4 weeks since prior IV chemotherapy and recovered

- More than 1 year since prior hepatic arterial cisplatin

- More than 4 months since other prior hepatic arterial chemotherapy

Endocrine therapy

- Not specified


- No prior external hepatic radiotherapy for HCC


- Not specified


- No other concurrent therapy for HCC

- No other concurrent investigational agents

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival as assessed by tumor progression in the treated lobe of the liver

Safety Issue:


Principal Investigator

Brian I. Carr, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236