NCT02323360

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

4.9 years

First QC Date

December 11, 2014

Last Update Submit

October 23, 2019

Conditions

Hepatocellular Carcinoma

Keywords

SBRTTACETAE

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • progression free-survival

    1.5 years

  • overall survival

    1.5 years

  • toxicity (incidence of acute and late complications)

    1.5 years

Study Arms (2)

Stereotactic body radiation therapy

EXPERIMENTAL

HCC after incomplete TAE or TACE treated by SBRT

Radiation: SBRT

TACE/TAE

ACTIVE COMPARATOR

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

Procedure: TACE

Interventions

SBRTRADIATION

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

Also known as: Stereotactic body radiation therapy
Stereotactic body radiation therapy
TACEPROCEDURE

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

Also known as: Transcatheter arterial chemoembolization
TACE/TAE

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

Related Publications (1)

  • 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.

    PMID: 36421345DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 23, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

IT(1)