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

Not Applicable

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: SBRT; Procedure: TACE

• Registration Number: NCT02323360
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Status Verified: 2019-10
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic body radiation therapy	SBRT	HCC after incomplete TAE or TACE treated by SBRT
TACE/TAE	TACE	HCC after incomplete TAE or TACE treated by a new cycle of TAE or TACE

Primary Outcome Measures

Name	Time	Method
Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)	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.

Secondary Outcome Measures

Name	Time	Method
overall survival	1.5 years
toxicity (incidence of acute and late complications)	1.5 years	incidence of acute and late complications
progression free-survival	1.5 years

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy