Condition category
Cancer
Date applied
24/08/2005
Date assigned
09/09/2005
Last edited
17/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Contact information

Type

Scientific

Primary contact

Prof James Garden

ORCID ID

Contact details

The University of Edinburgh
Clinical and Surgical Sciences (Surgery)
Room F3307
Ward 106
Royal Infirmary
51
Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00079027

Protocol/serial number

HE3001

Study information

Scientific title

Acronym

HEP-1

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.hep1.bham.ac.uk/HEP1-PatientGeneralInfo-v1.5.pdf

Condition

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

Phase

Not Applicable

Drug names

Doxorubicin

Primary outcome measures

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 trial start date

01/10/2005

Overall trial end date

01/10/2010

Reason abandoned

Objectives no longer viable

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

280

Participant 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

Recruitment start date

01/10/2005

Recruitment end date

01/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Edinburgh
Edinburgh
EH16 4SA
United Kingdom

Sponsor information

Organisation

The University of Birmingham and University of Edinburgh (UK)

Sponsor details

Research & Enterprise Services
Muirhead Tower
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.cancerstudies.bham.ac.uk/trials/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C9041/A4578)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes