Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
03/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23449352

Publication citations

Additional files

Editorial Notes

As of 11/08/09 this record has been extensively updated. All updates can be found under the relevant field with the above update date. Please also note that this trial has been extended, the initial end date was listed as 31/10/2005.