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

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SBRT
TACE
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring SBRT, TACE, TAE

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Humanitas Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stereotactic body radiation therapy

TACE/TAE

Arm Description

HCC after incomplete TAE or TACE treated by SBRT

HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE

Outcomes

Primary Outcome Measures

Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
This is a study designed to evaluate the efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE.

Secondary Outcome Measures

progression free-survival
overall survival
toxicity (incidence of acute and late complications)
incidence of acute and late complications

Full Information

First Posted
December 11, 2014
Last Updated
October 23, 2019
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02323360
Brief Title
A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
too slow enrollment
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
SBRT, TACE, TAE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic body radiation therapy
Arm Type
Experimental
Arm Description
HCC after incomplete TAE or TACE treated by SBRT
Arm Title
TACE/TAE
Arm Type
Active Comparator
Arm Description
HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic body radiation therapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
Transcatheter arterial chemoembolization
Intervention Description
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
Primary Outcome Measure Information:
Title
Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
Description
This is a study designed to evaluate the efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE.
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
progression free-survival
Time Frame
1.5 years
Title
overall survival
Time Frame
1.5 years
Title
toxicity (incidence of acute and late complications)
Description
incidence of acute and late complications
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

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

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