A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoper… (NCT02323360) | Clinical Trial Compass
TerminatedNot Applicable
A Trial on SBRT After Incomplete TAE or TACE Versus Exclusive TAE or TACE For Treatment of Inoperable HCC
Stopped: too slow enrollment
Italy41 participantsStarted 2014-11
Plain-language 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.
Who can participate
Age range18 Years – 95 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Local control (efficacy of SBRT in selected HCC patients with an incomplete response after TACE/TAE)