Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)

Tracking Information
First Submitted Date ICMJE	March 8, 2004
First Posted Date ICMJE	March 9, 2004
Last Update Posted Date	December 18, 2013
Study Start Date ICMJE	April 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: March 14, 2008)	Overall survival
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00079027 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 23, 2007)	Overall response; Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks; Time to progression as assessed by RECIST criteria; Toxicity; Health economics; Proteomic and immunological analysis
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
Official Title ICMJE	A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
Brief Summary	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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Primary Purpose: Treatment
Condition ICMJE	Liver Cancer
Intervention ICMJE	Drug: doxorubicin hydrochloride; Procedure: hepatic artery embolization
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: November 8, 2006)	280
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00079027
Other Study ID Numbers ICMJE	CDR0000353298; CRUK-HEP-1; EU-20340; ISRCTN78345798
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	University Hospital Birmingham
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: O. J. Garden Royal Infirmary of Edinburgh at Little France
PRS Account	National Cancer Institute (NCI)
Verification Date	May 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP