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)
18 Years
N/A
Both
Liver Cancer
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)
OBJECTIVES:
Primary
- 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.
Secondary
- 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
disease.
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
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 12 weeks
Hematopoietic
- 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
Hepatic
- 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
Renal
- Creatinine < 2.5 mg/dL
Cardiovascular
- No symptomatic congestive heart failure
- No severe peripheral vascular disease that would preclude catheterization
Other
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- 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
Radiotherapy
- No prior external hepatic radiotherapy for HCC
Surgery
- Not specified
Other
- No other concurrent therapy for HCC
- No other concurrent investigational agents
Type of Study:
Interventional
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:
No
Principal Investigator
Brian I. Carr, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Federal Government
Study ID:
CDR0000425333
NCT ID:
NCT00109954
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
Name | Location |
|---|---|
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
