Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Tim Meyer
ORCID ID
Contact details
Department of Oncology and Radiotherapy
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom
+44 (0)20 7794 0500 ext 8364
t.meyer@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256130934
Study information
Scientific title
A randomised, open label controlled trial of trans-arterial chemoembolisation vs embolisation alone in non-resectable hepatocellular carcinoma
Acronym
TACE
Study hypothesis
To investigate whether there is a difference in terms of overall survival, time to progression, response rate, quality of life and toxicity between the two treatment arms.
Ethics approval
Not provided at time of registration
Study design
Randomised open-label active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Liver cancer
Intervention
Current information as of 11/08/2009:
Single centre phase III randomised controlled trial comparing trans-arterial chemoembolisation vs embolisation alone
1. Treatment arm - trans-arterially administered cisplatin followed by embolisation
2. Control arm - Embolisation only
Initial information at time of registration:
Single centre phase III randomised controlled trial comparing trans-arterial chemoembolisation vs embolisation alone
Intervention type
Drug
Phase
Phase III
Drug names
Cisplatin
Primary outcome measure
1. Overall survival
2. Quality of life
3. Toxicity
4. Objective response rates
Secondary outcome measures
Not provided at time of registration
Overall trial start date
14/10/2003
Overall trial end date
30/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Added 11/08/2009:
1. Evidence of HCC as diagnosed by either histological means; or as evidenced by a focal lesion >2 cm with arterial hypervascularisation detected on two radiological studies (any two of ultrasound, CT, MRI or angiography) in a patient with a background of cirrhosis; or by a single radiological study with an a-fetoprotein greater than 400 ng/ml (1)
2. The patient must not be a candidate for surgical resection of the tumour but may be suitable for transplantation
3. The patient must have either a solitary hepatic tumour >3 cm in diameter or multifocal disease as evidenced by CT or MRI scanning.
4. Aged ≥16 years and estimated life expectancy >3 months
5. ECOG performance status ≤ 2
6. Adequate haematological function
7. Adequate clotting function: INR ≤ 1.5
8. GFR ≥ 50ml/min
9. Adequate liver function
10. Capable of giving written informed consent
11. Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 3 months after completion of treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
196
Participant exclusion criteria
Added 11/08/2009:
1. Extra-hepatic metastases
2. Prior treatment for HCC
3. Active sepsis or bleeding
4. Hepatic encephalopathy
5. Ascites refractory to diuretic therapy
6. Documented occlusion of the hepatic artery or portal vein
7.Hypersensitivity to intravenous contrast agents
8. Pregnant or lactating women
9. History of prior malignancy
10. Any evidence of severe or uncontrolled systemic diseases or laboratory finding
11. Any psychiatric or other disorder (eg brain metastases) likely to impact on informed consent
Recruitment start date
14/10/2003
Recruitment end date
30/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Free Hampstead NHS Trust
London
NW3 2QG
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Royal Free Hampstead NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23449352