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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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
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
Humanitas Research Hospital
Rozzano, Milan, Italy
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.
Time frame: 1.5 years
progression free-survival
Time frame: 1.5 years
overall survival
Time frame: 1.5 years
toxicity (incidence of acute and late complications)
incidence of acute and late complications
Time frame: 1.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.