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11 February 2012
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| [ Print-friendly version ] |
| A randomised, open label controlled trial of trans-arterial chemoembolisation vs embolisation alone in non-resectable hepatocellular carcinoma |
| ISRCTN | ISRCTN63349435 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised, open label controlled trial of trans-arterial chemoembolisation vs embolisation alone in non-resectable hepatocellular carcinoma |
| Scientific title | |
| Acronym | TACE |
| Serial number at source | N0256130934 |
| 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.
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 |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised open label active controlled parallel group trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Liver cancer |
| Participants - inclusion criteria |
Added 11/08/09:
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 |
| Participants - exclusion criteria |
Added 11/08/09:
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 |
| Anticipated start date | 14/10/2003 |
| Anticipated end date | 30/04/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 196 |
| Interventions |
Current information as of 11/08/09
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 |
| Primary outcome measure(s) |
1. Overall survival
2. Quality of life 3. Toxicity 4. Objective response rates |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The Royal Free Hampstead NHS Trust (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Tim Meyer |
| Address |
Department of Oncology and Radiotherapy
Royal Free Hampstead NHS Trust Pond Street Hampstead |
| City/town | London |
| Zip/Postcode | NW3 2QG |
| Country | United Kingdom |
| Tel | +44 (0)20 7794 0500 ext 8364 |
| Fax | +44 (0)20 7794 3341 |
| t.meyer@ucl.ac.uk | |
| Sponsor | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Address |
The Department of Health,
Richmond House, 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 30/09/2004 |
| Last edited | 11/08/2009 |
| Date ISRCTN assigned | 30/09/2004 |
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| © 2012 ISRCTN unless otherwise stated. | |
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