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

Hepatocellular Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02323360
• Other study ID #: 1315
• Status: Terminated
• Phase: N/A
• Start date: November 2014
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

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

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression free-survival		1.5 years
Secondary	overall survival		1.5 years
Secondary	toxicity (incidence of acute and late complications)	incidence of acute and late complications	1.5 years