A randomised, open label controlled trial of trans-arterial chemoembolisation vs embolisation alone in non-resectable hepatocellular carcinoma

ISRCTN	ISRCTN63349435
DOI	https://doi.org/10.1186/ISRCTN63349435
Protocol serial number	N0256130934
Sponsor	Department of Health
Funder	The Royal Free Hampstead NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 26/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-comparing-treatment-for-primary-liver-cancer-that-cannot-be-removed-with-surgery

Contact information

Dr Tim Meyer
Scientific

Department of Oncology and Radiotherapy
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Phone	+44 (0)20 7794 0500 ext 8364
Email	t.meyer@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised open-label active-controlled parallel-group trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	A randomised, open label controlled trial of trans-arterial chemoembolisation vs embolisation alone in non-resectable hepatocellular carcinoma
Study acronym	TACE
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Cisplatin
Primary outcome measure(s)	1. Overall survival 2. Quality of life 3. Toxicity 4. Objective response rates
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	196
Key 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
Key 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
Date of first enrolment	14/10/2003
Date of final enrolment	30/04/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Free Hampstead NHS Trust

London
NW3 2QG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/04/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
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.