Extrait

Background and study aims Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It grows a large number of blood vessels that get most of their blood supply from the hepatic artery (one of the main arteries to the liver) . As the rest of the liver tissue gets it blood supply from the portal vein, doctors can treat HCC by cutting off the blood supply to the tumour using a technique called transarterial chemoembolization (TACE). This involves injecting the arteries feeding the liver tumour with a material, often a gelatin sponge which may be soaked with a chemotherapy drug, to block the artery. The sponge traps the chemotherapy inside the liver so that they are concentrated where the tumours are. DEB-TACE is a new way type of TACE whereby special beads containing the chemotherapy drugs are injected into the hepatic arteries and are then slowly released to threat the tumours. It is possible that DEB-TACE is less toxic (harmful) than standard methods and have fewer side effects. This study is looking at whether DEB-TACE is as successful at treating HCC as these other TACE methods. Who can participate? Patients aged 18 or over with HCC. What does the study involve? All participants are treated with DEB-TACE. They undergo at least 2 sessions of treatment, 2 months apart. All other treatment sessions after this are performed according to results of regular magnetic resonance imaging (MRI) or computed tomography (CT) assessments. All patients are followed up to see how they progress over the next two years. This includes checking for evidence of toxicity both during the DEB-TACE procedure and afterwards, looking at how the tumour responds to the treatment though MRI or CT and assessing for how long it is after treatment before the tumour begins to grow again. What are the possible benefits and risks of participating? The potential benefits are to achieve an effective treatment of the disease with much less toxic consequences than other treatment methods. The risks in being submitted to this new treatment are the occurrence of rare, but possible, unexpected side effects. Where is the study run from? INCA - Brazilian National Cancer Institute When is the study starting and how long is it expected to run for? August 2009 to December 2010 Who is funding the study? INCA - Brazilian National Cancer Institute Who is the main contact? Dr Jose Hugo Luz [email protected]

Critère d'inclusion

• primary liver cancer

Liens

• isrctn