Trial record 1 of 1 for:    NCT01381211
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Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of Hepatocellular Carcinoma (HCC) (TRACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01381211
First received: June 14, 2011
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

Hepatocellular carcinoma (HCC) is a primary malignant tumor of the liver that accounts for an important health problem worldwide. In only 10% - 15% of all patients with HCC, tumors are considered resectable at presentation. In contrast to metastatic liver disease, there is no role for systemic chemotherapy in the treatment of HCC. Today only evidence is available for Sorafenib, a tyrosine kinase inhibiting agent. The arsenal of non-surgical therapies can roughly be divided into local ablative, transarterial and systemic therapies. In well selected patients, local ablative therapy can offer favorable long term results.

For patients with disease confined to the liver, but locally more advanced, transarterial treatment modalities are proposed. These therapies exploit the dual blood supply to the liver. HCC derives its blood supply almost entirely from the hepatic artery, while liver parenchyma derives > 75% of its blood supply from the portal vein. Antitumoral agents, such as cytotoxic drugs or radionuclides, can be delivered in close proximity of the tumor.

Examples of transarterial therapies are: transarterial chemoembolization (TACE), bland transarterial embolization (TAE), transarterial chemoembolization with drug eluting beads (TACE-DEB) and transarterial radioembolization with Iodine-131 or Yttrium-90.

TACE is currently the gold standard for treatment of patients with intermediate stage HCC, with a reported median survival of around 17 months. A novel development in the TACE treatment for HCC is the drug-eluting bead (DEB). Recently performed small clinical trials reported the efficacy of DEBs in the treatment of intermediate stage HCC, which is substantially higher compared to conventional TACE.

Yttrium-90 radioembolization (90Y-RE) is a relatively recently developed technique which implements transarterial administration of minimally embolic microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.

In this study the investigators want to prospectively compare TACE-DEB and 90Y-RE, two novel treatments that both have theoretical and/or proven advantages compared to the use of conventional TACE, in patients with intermediate stage HCC.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: TACE-DEB
Drug: 90Y-RE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of HCC: A Multicenter Randomized Controlled Trial (TRACE Trial)

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Time to Progression (TTP). [ Time Frame: Patients will be followed over a 2 years period. ] [ Designated as safety issue: No ]
    Tumor progression is defined according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) response evaluation criteria. The mRECIST evaluation criteria define progressive disease by the implication of target lesions response, non-target lesions response and the occurrence of new lesions.


Secondary Outcome Measures:
  • Time to Local Progression (TLP). [ Time Frame: Since start of treatment untill local tumor progression with a maximum of 2 years follow up. ] [ Designated as safety issue: No ]
    In both study arms, treatment is done selectively for the lesions within the perfusion area (may be lobar, segmental or subsegmental), as visualized with Cone-Beam CT prior to intervention.

  • Survival of patients dedicated to either treatment arm. [ Time Frame: Patients are followed for up to 2 years. ] [ Designated as safety issue: No ]
    Survival of patients is followed.

  • Quality of life [ Time Frame: Before treatment and after treatment on a 3 monthly interval during 2 years. ] [ Designated as safety issue: No ]
    Quality of life as measured with The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) scale, The Short Form (36) Health Survey, EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) and European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ30).

  • Tumor response to therapy according to mRECIST criteria [ Time Frame: Before treatment and after treatment on a 3 monthly interval during 2 years. ] [ Designated as safety issue: Yes ]
    European Association for the Study of the Liver (EASL) response will be obtained based on the following: complete response, partial response, stable disease.

  • Treatment-related costs. [ Time Frame: After follow up of 2 year. ] [ Designated as safety issue: No ]
    Treatment-related costs, in terms of cost of therapy and number of hospitalization days, in these patients.

  • Toxicities and adverse events (recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0) [ Time Frame: 6 months following last treatment ] [ Designated as safety issue: No ]
    The number of patients with AEs, SAEs and SUSARs and the total number of AEs, SAEs and SUSARs in both treatment groups.


Estimated Enrollment: 140
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Yttrium-90 radioembolization (90Y-RE) Drug: 90Y-RE
Glass Yttrium-90 microspheres (TheraSphere®; MDS Nordion Inc.) will be used
Active Comparator: Transarterial chemoembolization with drug eluting beads
Transarterial chemoembolization is performed with drug eluting beads, polyvinyl alcohol-based microspheres (DC Beads, Biocompatibles) loaded with the chemotherapeutic agent doxorubicin.
Drug: TACE-DEB
Transcatheter arterial chemoembolization (TACE) is performed with drug eluting beads (DEB), polyvinyl alcohol-based microspheres loaded with the chemotherapeutic agent doxorubicin.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • The diagnosis HCC is confirmed by typical appearance on imaging or cytohistological evaluation (liver biopsy).
  • Accurate staging:

MRI of the liver CT-scan of the abdomen and thorax bone scintigraphy, only in case of clinical symptoms suggestive of skeletal metastases.

Exclusion Criteria:

  • Hypersensitivity to doxorubicin
  • Pregnancy or breastfeeding
  • Age under 18 years
  • Child-Pugh score >B7
  • ECOG performance status (PST) > 1
  • Bilirubin > 2.6 mg/dl
  • AST/ALT >5x upper limit of normal (ULN)
  • >50% of liver involvement
  • Main portal vein (right, left or common trunk) thrombosis
  • Extra-hepatic disease
  • Previous treatment of study target lesions
  • 99mTc-labelled macroaggregated albumin (99mTc-MAA) scintigraphy shows lack of MAA uptake in tumor (photopenic lesion)
  • Activity > 610 MBq and activity reduction would imply a liver target dose > 80 Gy
  • patients who are declared incompetent or suffering from physic disorders that make a comprehensive judgement impossible, such as psychosis.
  • Unmanageable intolerance for contrast medium
  • Life expectancy < 3 months or otherwise impossible follow-up
  • Inadequate bone marrow, liver and/or renal function
  • other contraindications to hepatic embolization procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381211

Contacts
Contact: L Defreyne, PhD, MD (0)9/332 2938 ext +32 luc.defreyne@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: L Defreyne, PhD, MD    (0)9/332 2938 ext +32    luc.defreyne@ugent.be   
Principal Investigator: L Defreyne, PhD, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Luc Defreyne, MD, PhD University Hospital, Ghent
  More Information

No publications provided by University Hospital, Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01381211     History of Changes
Other Study ID Numbers: 2011/050
Study First Received: June 14, 2011
Last Updated: June 6, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
Intermediate stage hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014