A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
- Compare the survival of patients with advanced unresectable primary hepatocellular
carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin
- Compare the response rate in patients treated with these regimens.
- Compare time to progression in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the health economic implications of these regimens in these patients.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to participating center, stage of disease, and alpha-fetoprotein levels (< 500
ng/mL vs ≥ 500 ng/mL). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control arm): Patients receive doxorubicin hydrochloride IV over 3-5 minutes on
day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II (chemoembolization arm): Patients undergo transarterial chemoembolization using
DC Bead and doxorubicin hydrochloride. Chemoembolization repeats every 8 weeks for a
total of 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at weeks 10 and 24.
Patients are followed at 4 weeks and then every 12 weeks thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
O. J. Garden
Royal Infirmary of Edinburgh at Little France
United States: Federal Government