A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC

October 23, 2019 updated by: Istituto Clinico Humanitas

A Randomised Phase III Trial on Stereotactic Body Radiotherapy (SBRT) After Incomplete Transcatheter Arterial Embolization (TAE) or Chemoembolization (TACE) Versus Exclusive TAE or TACE for Inoperable Hepatocellular Carcinoma (HCC)

The trial is a multicentre, prospective, randomised controlled, unblinded, parallel-group superiority trial of SBRT versus standard TAE/TACE for the curative treatment of inoperable HCC treated with a TAE/TACE incomplete cycle.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this phase III study patients with inoperable HCC single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions or to a new cycle of TAE or TACE. A total of 80 patients (40 in each arm) will be recruited into the trial over a 2 years period and will be randomised on an equal basis to either SBRT or TAE/TACE. The follow-up period will be finished 1.5 years after the final patient is randomised.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • HUMANITAS Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Karnofsky index >70%
  • Child-Turgotte-Pugh A or B liver score.
  • An initial diagnosis of primary HCC or recurrence.
  • A technically unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
  • HCC (single nodule ≤ 5 cm or max 3 nodules ≤ 3 cm) diagnosed by histology or non-invasive EASL criteria
  • Baseline CT or MRI and bone scan without evidence of radiologically definable major vascular invasion or extrahepatic disease
  • Hb >10.5.0 g/%, WBC >3.000 cells/mm3, platelets >50.000 cells/mm3, bilirubin <2 mg/dl, aspartate and alanine aminotransferase levels <5 times upper normal limit, and prothrombin time-international normalized ratio ≤ 2;
  • Serum creatinine <1.7 mg/dl
  • Previously incomplete TAE or TACE with radiologically defined residual disease.
  • Informed consent

Exclusion Criteria:

  • Extrahepatic disease and refractory ascites.
  • Previous abdominal radiation therapy (RT)
  • Hemorrhage/bleeding event = Grade 3 within 4 weeks of enrollment in the study.
  • Pregnant or breastfeeding patients.
  • Patients with uncontrolled infections or HIV seropositive patients.
  • Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic body radiation therapy
HCC after incomplete TAE or TACE treated by SBRT
Radiation: SBRT
Patients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions
Other Names:
  • Stereotactic body radiation therapy
Active Comparator: TACE/TAE
HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE
Procedure: TACE
Patients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to a new cycle of TAE or TACE
Other Names:
  • Transcatheter arterial chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
Time Frame: 1.5 years
This is a study designed to evaluate the efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE.
1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free-survival
Time Frame: 1.5 years
1.5 years
overall survival
Time Frame: 1.5 years
1.5 years
toxicity (incidence of acute and late complications)
Time Frame: 1.5 years
incidence of acute and late complications
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

December 11, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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