Clinical trial NCT02323360: A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: SBRT
TACE
TAE
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)
timeFrame: 1.5 years
Secondary outcomes:
measure: progression free-survival
timeFrame: 1.5 years
measure: overall survival
timeFrame: 1.5 years
measure: toxicity (incidence of acute and late complications)
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
References: