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
Allocation: Randomized, Primary Purpose: Treatment
Progression-free survival as assessed by tumor progression in the treated lobe of the liver
Brian I. Carr, MD
University of Pittsburgh
United States: Federal Government
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|