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Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRWTH Aachen University

About this trial

The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HCC (diagnosis: histological or radiological)

Age: 18-80

Number of lesions 1-3 lesions

Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm

Disqualifiers

Evidence of extrahepatic disease (lymph node or distant metastases)

Evidence of macroscopic vascular invasion

Evidence of an arterio-portal or arterio-venous fistulas

History of previous malignancy

Trial design

Design model

Single group

Treatments tested in this trial

  • TACE

    Procedure/Surgery

    1-2 session TACE before SBRT according to the preference of the interventional radiologist. Goal of TACE is the complete emnbolization of the HCC-nodules. It is allowed to use both conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE) according to the interventional radiologist preference.

  • SBRT

    Radiation

    SBRT should be 1 month after last TACE. This can be extended till 2 months if indicated. However, prolongation of the gap between TACE and SBRT is not encouraged. Treatment center should choose one of fractionation schedule mentioned allowed in the study, in order to achieve a balance between dose applied for tumor control and constraints for OAR PTV Dose in 5 / 8 fractions (Gy) EQD2 (α/β 10Gy) 5x 8-6 Gy @ 83% isodose = 40-30 Gy (60-40 Gy) 8 x 6-4.5 Gy @ 83% isodose = 48-36 Gy (64-43.5 Gy)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TACE+SBRT.Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

1-year local control rate

After one year from the treatment, the precentage with alive subjects with no signs of local progression (the irradiated lesion). Local progression defined as more than 20% increase in diameter of enhancing tumor on contrast-enhanced CT scan in arterial phase or a new tumor mass within the original tumor volume according to modified RECIST criteria (mRECIST)

Time frame
12 Months

Secondary outcomes

1

1- year progression free survival

After one year from the end of the treatment, the percentage of alive subjects without the apperance of new hepatic and/or extra-heaptic new lesions outside the SBRT-field. This will be measured using contrast-enhanced CT scan Liver/Abdomen and Thorax

Time frame
12 Months
2

Qualtiy of life based on EORTC QLQC30

alive subjects will fill quality of life questionnaires (EORTC QLQC30) before the treatment and after 3,6 and 12 months after. The results before and after the treatment will be presented in comaprsion to the reference data.

Time frame
12 Months
3

Quality of life based on EORTC QLQ-HCC18

alive subjects will fill quality of life questionnaires (EORTC QLQ-HCC18) before the treatment and after 3,6 and 12 months after. The results before and after the treatment will be presented in comaprsion to the reference data.

Time frame
12 Months
4

Possibility of a secondary resection/organ transplant

Possibility of a secondary resection/organ transplant (Yes/ No)

Time frame
3 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RWTH Aachen University

Lead sponsor

Source ClinicalTrials.gov
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