Liver CancerPhase 3NCT00079027
Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
A Phase 3 study testing doxorubicin hydrochloride and hepatic artery embolization in people with Liver Cancer, run by University Hospital Birmingham at 10 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- doxorubicin hydrochloride and hepatic artery embolization
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Apr 2004to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Cancer Research UK Clinical Trials Unit - Birmingham
Birmingham, England, B15 2TT
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8HW
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
Royal Infirmary of Edinburgh at Little France
Edinburgh, Scotland, EH16 4SA
Royal Infirmary Edinburgh
Edinburgh, Scotland, EH3 9YW
West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT
Royal Liverpool University Hospital
Liverpool, England, L69 3GA
Hammersmith Hospital
London, England, W12 OHS
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN
Royal South Hants Hospital
Southampton, England, SO14 0YG
About this study
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.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- doxorubicin hydrochloride, hepatic artery embolization
- Keywords
- advanced adult primary liver cancer, adult primary hepatocellular carcinoma
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic artery embolizationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2004 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- O. J. Garden, Study chair, Royal Infirmary of Edinburgh at Little France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079027
- Sponsor's protocol ID
- CDR0000353298
- Other IDs
- CRUK-HEP-1, EU-20340, ISRCTN78345798
- Status last verified
- May 2007
- First submitted
- 8 Mar 2004
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00079027
- Acronym / sponsor ID
- CDR0000353298
- Conditions
- Liver Cancer
- Keywords
- advanced adult primary liver cancer, adult primary hepatocellular carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Study start
- Apr 2004
- First posted
- 9 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxorubicin hydrochloride | Drug | – |
| hepatic artery embolization | Procedure or surgery | – |
Primary outcome
Overall survival
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
O. J. Garden study chair
Royal Infirmary of Edinburgh at Little France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing doxorubicin hydrochloride and hepatic artery embolization in people with Liver Cancer, run by University Hospital Birmingham at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.