Condition category
Cancer
Date applied
08/10/2016
Date assigned
14/10/2016
Last edited
14/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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's 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's National Cancer Institute

Who is the main contact?
Dr Jose Hugo Luz
jhugoluz@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Hugo Luz

ORCID ID

http://orcid.org/0000-0002-1222-850X

Contact details

Rua Assunção 159 apto 1001 bl 02
Rio de Janeiro
22251-030
Brazil
+5521999995225
jhugoluz@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Approval #078/09

Study information

Scientific title

DEB TACE for intermediate and advanced hepatocellular carcinoma (HCC) – initial experience in a Brazilian Cancer Center

Acronym

Study hypothesis

Treatment of hepatocellular carcinoma with anew device known as drug-eluting beads may offer an at least equal result to standard TACE with significantly less toxicity.

Ethics approval

Brazilian National Cancer Institute (INCA) Ethics Committee, 13/07/2009, ref: 078/09

Study design

Prospective non-randomized phase II study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Primary liver cancer

Intervention

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.

Intervention type

Device

Phase

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/08/2009

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

21

Participant 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

Recruitment start date

01/08/2009

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Brazil

Trial participating centre

INCA - Brazilian's National Cancer Institute
Praça Cruz Vermelha, 23. Centro.
Rio de Janeiro
20230-130
Brazil

Sponsor information

Organisation

INCA - Brazilian's National Cancer Institute

Sponsor details

Praça Cruz Vermelha. Centro
Rio de Janeiro
20230-130
Brazil
+552132071624
jhugoluz@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www2.inca.gov.br/wps/wcm/connect/inca/portal/home

Funders

Funder type

Government

Funder name

INCA - Brazilian's National Cancer Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Submission for a peer-reviewed oncology medical journal.

IPD sharing plan:
Access to datasets are available upon request to Joana Emanuele (inca.interv@gmail.com) or
Jose Hugo Luz (jhugoluz@gmail.com)

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes