A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
18 Years
N/A
Both
Liver Cancer
Trial Information
A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
- Advanced, unresectable disease
- No clinically significant ascites
- No modified Child-Pugh class C liver disease
- No main portal vein occlusion/involvement
- No extrahepatic tumor of any kind
PATIENT CHARACTERISTICS:
Age
- 18 and over (16 and over for patients residing in Scotland)
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Hemoglobin ≥ 8.5 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin < 5.0 mg/dL
- Transaminases < 2.5 times upper limit of normal (ULN)
- INR < 1.5
Renal
- Creatinine < 2 times ULN
Cardiovascular
- No New York Heart Association class III or IV cardiac disease
- No acute angina
- No significant peripheral vascular disease
- No thrombosis of main portal vein
- LVEF ≥ 50%
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other concurrent serious medical condition
- No serious infection
- No psychological, familial, sociological, or geographical factors that would preclude
study compliance
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or
non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy for advanced unresectable HCC
Chemotherapy
- No prior systemic or regional chemotherapy
- No prior chemotherapy for advanced unresectable HCC
- No other concurrent anticancer chemotherapy
Endocrine therapy
- No prior hormonal therapy for advanced unresectable HCC
Radiotherapy
- No prior radiotherapy for advanced unresectable HCC
- No other concurrent anticancer radiotherapy
Surgery
- More than 7 days since prior major surgery
- More than 3 days since prior laparoscopy
Other
- More than 4 weeks since prior investigational agents
- More than 6 weeks since prior ablative therapy and must have radiological evidence of
progression if ablated site is the only site of disease
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
O. J. Garden
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Infirmary of Edinburgh at Little France
Authority:
United States: Federal Government
Study ID:
CDR0000353298
NCT ID:
NCT00079027
Start Date:
April 2004
Completion Date:
Related Keywords:
- Liver Cancer
- advanced adult primary liver cancer
- adult primary hepatocellular carcinoma
- Carcinoma
- Liver Neoplasms
- Carcinoma, Hepatocellular
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