A randomised clinical trial evaluating the benefits of doxorubicin chemoembolisation (CEM) versus systemic doxorubicin in patients with unresectable, advanced hepatocellular carcinoma (HCC)
| ISRCTN | ISRCTN78345798 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78345798 |
| ClinicalTrials.gov number | NCT00079027 |
| Secondary identifying numbers | HE3001 |
- Submission date
- 24/08/2005
- Registration date
- 09/09/2005
- Last edited
- 17/05/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Prof James Garden
Scientific
Scientific
The University of Edinburgh
Clinical and Surgical Sciences (Surgery)
Room F3307, Ward 106
Royal Infirmary
51, Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.hep1.bham.ac.uk/HEP1-PatientGeneralInfo-v1.5.pdf |
| Scientific title | |
| Study acronym | HEP-1 |
| Study objectives | To test the hypothesis that patients with advanced, unresectable HCC treated with CEM will have an improved survival compared to those treated with single agent Doxorubicin. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Unresectable, advanced hepatocellular carcinoma |
| Intervention | Control Arm: Single agent doxorubicin, max dose 60 mg/m^2 IV day 1, repeated once every 3 weeks for a max of 6 cycles Treatment Arm: Chemoembolisation (CEM) using doxorubicin, repeated every 8 weeks for a max of 3 procedures |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Doxorubicin |
| Primary outcome measure | Survival |
| Secondary outcome measures | 1. Overall Response (determined by RECIST criteria) 2. Time to progression (determined by RECIST criteria) 3. Toxicity 4. QoL 5. Health economics 6. Proteomics 7. Immunological |
| Overall study start date | 01/10/2005 |
| Completion date | 01/10/2010 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 280 |
| Key inclusion criteria | 1. Histological or cytological diagnosis or The European Association for the Study of the Liver (EASL) criteria met for unresectable HCC 2. No prior systemic or regional chemotherapy 3. Aged greater than or equal to 18 years (or greater than or equal to 16 years in Scotland) 4. Laboratory parameters: 4.1. Haemoglobin (Hb) greater than or equal to 8.5 g/dl 4.2. Platelets greater than or equal to 100,000/mm^3 4.3. Absolute neutrophil count (ANC) greater than or equal to 1500/mm^3 4.4. International normalised ratio (INR) less than 1.5 4.5. Bilirubin less than or equal to 50 µm/L 4.6. Transaminases less than 2.5 x upper limit of normal (ULN) 4.7. Serum creatinine less than 2 x ULN 5. Eastern Coooperative Oncology Group (ECOG) performance status less than or equal to 2 6. Modified Pugh's Child B grade or better 7. Not of childbearing potential or using an approved method of contraception 8. Written informed consent |
| Key exclusion criteria | 1. New York Heart Association (NYHA) Class III/IV cardiac disease 2. Left ventricular ejection fraction (LVEF) of less than 50% or acute anginal symptoms 3. Thrombosis of main portal vein 4. Main portal vein occlusion/involvement 5. Patients whom in the opinion of the investigator have 'clinically significant ascites' 6. History of second malignancy within 5 years prior to trial entry, excepting cervical carcinoma-in-situ or non-melanotic skin cancer 7. Previous chemotherapy, radiotherapy, biological or hormone therapy given for hepatocellular carcinoma 8. Any ablative therapy for hepatocellular carcinoma within the last 6 weeks. Radiological evidence of progression is required if assessing a previously ablated site as the only site of disease. 9. Use of other investigational agent during the study or within 4 weeks of planned study entry 10. Major surgery within 7 days or laparoscopy within 3 days of trial entry 11. A serious co-existing medical condition including a potential serious infection or significant peripheral vascular disease 12. Psychological, familial, sociological or geographical factors considered likely to prevent compliance with the protocol 13. Presence of extrahepatic tumour of any kind |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
The University of Edinburgh
Edinburgh
EH16 4SA
United Kingdom
EH16 4SA
United Kingdom
Sponsor information
The University of Birmingham and University of Edinburgh (UK)
University/education
University/education
Research & Enterprise Services
Muirhead Tower
University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.cancerstudies.bham.ac.uk/trials/ |
|---|---|
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C9041/A4578)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
