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

Sponsor
RWTH Aachen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04996914
Collaborator
(none)
30
Enrollment
1
Arm
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: TACE
  • Radiation: SBRT
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: TACE+SBRT.

If a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session .

Procedure: TACE
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.

Radiation: SBRT
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) BED (α/β 10Gy) 5x 10 Gy @ 83% isodose = 50 Gy (100 Gy) 8 x 7.5 Gy @ 83% isodose = 60 Gy (105 Gy)

Outcome Measures

Primary Outcome Measures

  1. 1-year local control rate [12 Months]

    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)

Secondary Outcome Measures

  1. Qualtiy of life based on EORTC QLQC30 [12 Months]

    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.

  2. 1- year progression free survival [12 Months]

    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

  3. Quality of life based on EORTC QLQ-HCC18 [12 Months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

  • Sufficient non-tumorous liver volume (≥ 800 cm3)

  • Child Pugh Score: A5-6 or B7

  • BCLC A or B

  • Patient is illegible or refused surgical resection or orthotopic liver transplant

  • Blood work (within 2 weeks before registration):

  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³)

  • Platelets ≥50,000 cells/mm³

  • AST (and ALT) < 5 times ULN

  • Serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

  • 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

  • Active hepatitis B

  • Previous SIRT

  • Previous Sorafenib in the last 8 weeks

  • Pregnant and lactating females

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • RWTH Aachen University

Investigators

  • Principal Investigator: Michael J. Eble, Professor Dr. med., University medical center RWTH Aachen
  • Principal Investigator: Philipp Bruners, Professor Dr. med., University medical center RWTH Aachen
  • Study Chair: Ahmed Allam Mohamed, MBBS, MSc, MD, University medical center RWTH Aachen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT04996914
Other Study ID Numbers:
  • 20-341
First Posted:
Aug 9, 2021
Last Update Posted:
Aug 9, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Aug 9, 2021