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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: SBRT
* Procedure: TACE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic body radiation therapy<br>HCC after incomplete TAE or TACE treated by SBRT | Radiation: SBRT<br>* 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<br>* Other names: Stereotactic body radiation therapy;|
| Active Comparator: TACE/TAE<br>HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE | Procedure: TACE<br>* 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<br>* Other names: Transcatheter arterial chemoembolization;|

What is the study measuring?
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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) | 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 |  | 1.5 years | 
| overall survival |  | 1.5 years | 
| toxicity (incidence of acute and late complications) | incidence of acute and late complications | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBRT, TACE, TAE