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

NCT ID: NCT02323360

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2019-10-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic body radiation therapy

HCC after incomplete TAE or TACE treated by SBRT

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

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

TACE/TAE

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

Group Type: ACTIVE_COMPARATOR

TACE

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: RADIATION

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

Intervention Type: PROCEDURE

Other Intervention Names

Stereotactic body radiation therapy; Transcatheter arterial chemoembolization

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Research Hospital

Rozzano, Milan, Italy

Countries

Italy

References

Comito T, Loi M, Franzese C, Clerici E, Franceschini D, Badalamenti M, Teriaca MA, Rimassa L, Pedicini V, Poretti D, Solbiati LA, Torzilli G, Ceriani R, Lleo A, Aghemo A, Santoro A, Scorsetti M. Stereotactic Radiotherapy after Incomplete Transarterial (Chemo-) Embolization (TAE\TACE) versus Exclusive TAE or TACE for Treatment of Inoperable HCC: A Phase III Trial (NCT02323360). Curr Oncol. 2022 Nov 16;29(11):8802-8813. doi: 10.3390/curroncol29110692.

Reference Type: DERIVED

PMID: 36421345 (View on PubMed)

Other Identifiers

1315

Identifier Type: -

Identifier Source: org_study_id