Liver Cancer Clinical Trial
Official title:
A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping the cells from
dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and
keeping chemotherapy drugs near the tumor. It is not yet known whether doxorubicin is more
effective with or without chemoembolization in treating unresectable hepatocellular
carcinoma (liver cancer).
PURPOSE: This randomized phase III trial is studying doxorubicin given by infusion to see
how well it works compared to doxorubicin given by chemoembolization in treating patients
with advanced liver cancer than cannot be removed by surgery.
OBJECTIVES:
Primary
- Compare the survival of patients with advanced unresectable primary hepatocellular
carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin
hydrochloride chemoembolization.
Secondary
- 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
study.
;
Allocation: Randomized, Primary Purpose: Treatment
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