Treatment for primary liver cancer – initial experience with a new device in a Brazilian Cancer Center

ISRCTN ISRCTN16295622
DOI https://doi.org/10.1186/ISRCTN16295622
Secondary identifying numbers Approval #078/09
Submission date
08/10/2016
Registration date
14/10/2016
Last edited
01/03/2019
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

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
jhugoluz@gmail.com

Contact information

Dr Jose Hugo Luz
Scientific

Rua Assunção 159 apto 1001 bl 02
Rio de Janeiro
22251-030
Brazil

ORCiD logoORCID ID 0000-0002-1222-850X
Phone +5521999995225
Email jhugoluz@gmail.com

Study information

Study designProspective non-randomized phase II study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleDEB TACE for intermediate and advanced hepatocellular carcinoma (HCC) – initial experience in a Brazilian Cancer Center
Study objectivesTreatment 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(s)Brazilian National Cancer Institute (INCA) Ethics Committee, 13/07/2009, ref: 078/09
Health condition(s) or problem(s) studiedPrimary liver cancer
InterventionThe 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 typeDevice
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)
Primary outcome measure1. 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 measuresToxicity, 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 study start date01/08/2009
Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants21
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/08/2009
Date of final enrolment01/01/2010

Locations

Countries of recruitment

  • Brazil

Study participating centre

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

Sponsor information

INCA - Brazilian National Cancer Institute
Hospital/treatment centre

Praça Cruz Vermelha. Centro
Rio de Janeiro
20230-130
Brazil

Phone +552132071624
Email jhugoluz@gmail.com
Website http://www2.inca.gov.br/wps/wcm/connect/inca/portal/home
ROR logo "ROR" https://ror.org/055n68305

Funders

Funder type

Government

INCA - Brazilian National Cancer Institute

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planSubmission for a peer-reviewed oncology medical journal.
IPD sharing planAccess to datasets are available upon request to Joana Emanuele (inca.interv@gmail.com) or
Jose Hugo Luz (jhugoluz@gmail.com)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 06/02/2017 Yes No

Editorial Notes

01/03/2019: Internal review.
09/02/2017: Publication reference added.