|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
25 March 2019 |
|
Main ID: |
ISRCTN16295622 |
|
Date of registration:
|
14/10/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Treatment for primary liver cancer – initial experience with a new device in a Brazilian Cancer Center
|
|
Scientific title:
|
DEB TACE for intermediate and advanced hepatocellular carcinoma (HCC) – initial experience in a Brazilian Cancer Center |
|
Date of first enrolment:
|
01/08/2009 |
|
Target sample size:
|
21 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN16295622 |
|
Study type:
|
Interventional |
|
Study design:
|
Prospective non-randomized phase II study (Treatment)
|
|
Phase:
|
Phase II
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Jose Hugo
Luz |
|
Address:
|
Rua Assunção 159 apto 1001 bl 02
22251-030
Rio de Janeiro
Brazil |
|
Telephone:
|
+5521999995225 |
|
Email:
|
jhugoluz@gmail.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Patients 18 years old or above
2. Present with a Child A or B (Child-Pugh Classification) score
3. A PS equal or less than 2
4. A liver tumor compatible with a Barcelona clinic liver cancer (BCLC) stage B or C HCC which had not been previously submitted to transcatheter arterial chemoembolization (TACE) or any intra-arterial treatment
Exclusion criteria:
1. Performance status scale (PS - Karnofsky performance status scale) of 2 or less
2. No extrahepatic spread of the liver tumor
3. Child-Pugh classification A or B
4. 17 years of age or younger
5. Refusal to sign the Informed consent
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Primary liver cancer
Cancer
|
|
Intervention(s)
|
The interventions (Procedures called DEB TACE - Transarterial chemoembolization with drug-eluting beads), were done by a staff member of the interventional radiology team with experience with oncology interventions. Tow vials of the DEB TACE product DC Beads (2 mL, BioCompatibles Ltd., UK) with a diameter of 100 to 300 µm or 300 to 500 µm were loaded, per vial, with 75 mg of doxorubicin hydrochloride (37,5 mg/mL). Through the common femoral artery and using a diagnostic catheter (e.g. Cobra 5F) a microcatheter was placed as near as possible to the vessel irrigating the hepatic tumor. After a secure point was achieved by the tip of the microcatheter, researchers proceeded with the injection of the DC Beads loaded with doxorubicin mixed with contrast media and in a smooth fashion. The endpoint was to administer the whole two DC Beads vials or when flow of the tumor-nourishing artery reduced markedly. Total stasis of the tumor vascularity was avoided so it wouldn’t disturb the subsequent DEB TACE sessions.
The DEB TACE procedures were done at 2-month intervals during the first two sessions. From this point on new DEB TACE sessions were performed on demand accordingly to response in magnetic resonance (MR) and clinical outcome. Tumor response was evaluated with liver dedicated dynamic-enhanced MR of the abdomen and interpreted by body-imaging radiologists. Patients unable to perform MR were schedule to undergo computed tomography (CT). Clinical and laboratory tests were performed before and after each session and during hospitalizations, targeting the evaluation of the toxicity and quantification of adverse effects.
There was no control group.
|
|
Primary Outcome(s)
|
1. Tumor response, assessed via magnetic resonance imaging (MRI) or computed tomography (CT) if patient not able to withstand MRI
2. Progression-free survival, via clinical assessments performed at least every three months over a two year period
|
|
Secondary Outcome(s)
|
|
Toxicity, evaluated during the DEB TACE procedure, immediately after it and during hospital permanence. Assessed via telephone calls and regularly scheduled hospital patient visits over a two year period
|
|
Secondary ID(s)
|
|
Approval #078/09
|
|
Source(s) of Monetary Support
|
|
INCA - Brazilian National Cancer Institute
|
|
Ethics review
|
Status:
Approval date:
Contact:
Brazilian National Cancer Institute (INCA) Ethics Committee, 13/07/2009, ref: 078/09
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
01/12/2010 |
|
URL:
|
|
|
|