SBRT or TACE for Advanced HCC

NCT03338647 | Unknown Phase 3 DMC

• 1 other identifier: UAarhus HCC
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized study of stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) in locally advanced hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Stereotactic body radiation therapy; transarterial chemoembolization; SBRT; TACE

Outcome Measures

Primary Outcomes (1)

• Progression (total of local, intra- and extrahepatic)

  Modified RECIST

  1 year

Secondary Outcomes (7)

• Response

  3 months

• Local control of treated tumor

  1 year

• Intrahepatic failure

  1 year

• Extrahepatic failure

  1 year

• Overall survival

  1 year

Study Arms (2)

TACE

ACTIVE COMPARATOR

Transarterial chemoembolization with drug eluted beads or doxorubicin/lipiodol

Drug: DEB

SBRT

EXPERIMENTAL

Stereotactic radiation therapy with risk adapted dose prescription

Radiation: SBRT

Interventions

DEB DRUG

Infusion of DEB or doxorubin/lipiodol through catheter in the hepatic artery

Also known as: doxorubicin

TACE

SBRT RADIATION

High precision radiation therapy to the liver tumor(s)

SBRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCC (biopsy or radiological diagnostic (\>1 cm, enhancing in arterial phase and wash-out in later phases).
• Number of lesions: not more than 3 lesions
• Lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion)
• Child-Pugh A or B (\<7) on examination within 6 weeks prior to study entry
• BCLC Stage A/B
• Must be fit (eligible) for SBRT and TACE
• Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available
• Distance between GTV (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is \>10 mm
• All blood work obtained within 2 weeks prior to study entry with adequate organ function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets ≥50,000 cells/mm3
• Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
• Total bilirubin \< 2 mg/dL
• Prothrombin time/INR \< 1.4 (unless on Coumadin/Warfarin)
• Albumin ≥ 28 g/L

You may not qualify if:

• Not suitable for clinical trial or follow-up
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible). No active cancer therapy.
• Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE)
• Non-enhancing HCC on CT or CT-angio or
• Portal vein thrombosis/macroscopic venous invasion
• Arterio-portal and arterio-venous fistulas observed on pre-study imaging (if it is found during the TACE, the fistula may be embolized before injection of the drug).
• Evidence of metastatic disease including nodal or distant metastases.
• Previous TACE or radiation to the liver (including SIRT)
• Life-threatening condition (including untreated HIV and active hepatitis B/C)
• Detectable HBeAg and HBV viral load \> 20,000 IU/mL or
• HBeAg-negative chronic hepatitis B and HBV viral load \>2,000 IU/mL
• If HBV-DNA copy is higher than 500 copies/ml, anti-viral therapy, such as Entecavir followed by observation for 2 weeks.
• Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days

Sponsors & Collaborators

• University of Aarhus: lead
• International Atomic Energy Agency: collaborator

Study Sites (1)

Medanta

Delhi, National Capital Territory of Delhi, 122001, India

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Morten Høyer, PhD

CONTACT

+45 23282823; hoyer@aarhus.rm.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 9, 2017
• Study Start: October 26, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IN (1)