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 |
| Secondary identifying numbers | N0256130934 |
- 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
Contact information
Dr Tim Meyer
Scientific
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 |
|---|---|
| t.meyer@ucl.ac.uk |
Study information
| Study design | Randomised open-label active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 14/10/2003 |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Royal Free Hampstead NHS Trust
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
The Royal Free Hampstead NHS Trust (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 02/04/2013 | Yes | No |
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.
