Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
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.
Drug: doxorubicin hydrochloride
Procedure: hepatic artery embolization
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma|
- Overall survival [ Designated as safety issue: No ]
- Overall response [ Designated as safety issue: No ]
- Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks [ Designated as safety issue: No ]
- Time to progression as assessed by RECIST criteria [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Health economics [ Designated as safety issue: No ]
- Proteomic and immunological analysis [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
- Compare the survival of patients with advanced unresectable primary hepatocellular carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin hydrochloride chemoembolization.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079027
|Cancer Research UK Clinical Trials Unit - Birmingham|
|Birmingham, England, United Kingdom, B15 2TT|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8HW|
|Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Royal Liverpool University Hospital|
|Liverpool, England, United Kingdom, L69 3GA|
|London, England, United Kingdom, W12 OHS|
|Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN|
|Royal South Hants Hospital|
|Southampton, England, United Kingdom, SO14 0YG|
|Royal Infirmary of Edinburgh at Little France|
|Edinburgh, Scotland, United Kingdom, EH16 4SA|
|Royal Infirmary Edinburgh|
|Edinburgh, Scotland, United Kingdom, EH3 9YW|
|West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||O. J. Garden||Royal Infirmary of Edinburgh at Little France|