Transarterial Chemoembolization (TACE) With or Without Stereotactic Body Radiotherapy (SBRT) in Hepatocellular Carinoma

NCT03079778 | Withdrawn DMC

• 1 other identifier: 106681
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypothesis: Patients with hepatocellular carcinoma (HCC) have few options if they fail or are unable to undertake surgery, transarterial chemoembolization (TACE) and/or chemotherapy. Radiation (RT) in a range of doses has been combined with TACE in several case cohort studies demonstrating safety and a dramatic improvement in survival. Clearly these trials are subject to bias due to non-randomized selection, possible lack of generalizability to Canadian patients, and heterogeneous patient populations. Objective: Therefore, there is a high priority need to investigate the addition of RT to TACE in a randomized fashion to determine if we can improve survival in this rapidly growing poor prognosis patient population that have no other options. Methodology: TACE eligible patients with HCC will be randomized to TACE alone or TACE plus radiation (TACERT). They cannot be eligible for standard treatments such as transplant and resection. Primary endpoint will be time-to-intrahepatic-progression. Secondary endpoints will be response rate (Modified RECIST criteria), overall survival, local failure, extrahepatic failure, toxicity, quality of life and economic feasibility.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Intrahepatic progression

  Lesion growth as characterized by RECIST criteria

  2 years

Secondary Outcomes (5)

• Response rate - Modified RECIST criteria

  2 years

• Local failure - within 1 cm from the original tumor volume

  2 years

• Overall survival

  2 years

• Toxicity

  2 years

• QoL-quality of life

  2 years

Other Outcomes (2)

• Cost-benefit

  2 years

• Extrahepatic failure

  2 years

Study Arms (2)

TACE alone

ACTIVE COMPARATOR

Transarterial chemoembolization (TACE)

Procedure: transarterial chemoembolization

TACE plus RT

EXPERIMENTAL

Combination of transarterial chemoembolization and radiation (TACERT)

Procedure: transarterial chemoembolization; Radiation: TACE plus RT

Interventions

transarterial chemoembolization PROCEDURE

Transcatheter arterial chemoembolization (also called transarterial chemoembolization or TACE) is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply

TACE alone; TACE plus RT

TACE plus RT RADIATION

radiobiologically guided radiation

Also known as: radiobiological guided radiation

TACE plus RT

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCC (diagnosed through biopsy or radiological criteria)
• Age \>18 years of age
• Number of lesions: not more than 3 lesions
• Lesion size: up to 10 cm (and up to 10 cm cumulative diameter)
• Unilobar +/- segment 4
• Child-Pugh A within 6 weeks prior to study entry
• Barcelona Clinic (BCLC) Stage A/B
• Absence of comorbidities
• ECOG Performance Status 0-2
• Must be fit (eligible) for RT and TACE
• Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available
• All blood work obtained within 6 weeks prior to study entry with adequate organ marrow 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 \< 1.7 (unless on Coumadin/Warfarin) Albumin ≥ 28 g/L AST and ALT \< 5 times ULN Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min
• May have had previous surgery, ethanol injection and RFA to the liver
• No evidence of metastatic disease including nodal or distant metastases (clinically defined by each institution).

You may not qualify if:

• 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.
• Major vascular invasion/thrombus
• Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) Raoul et al (2011)
• Previous TACE and radiation to the liver (including SIRT )
• Life-threatening condition including untreated HIV and active hepatitis B/C
• Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (1)

• Jacob R, Turley F, Redden DT, Saddekni S, Aal AK, Keene K, Yang E, Zarzour J, Bolus D, Smith JK, Gray S, White J, Eckhoff DE, DuBay DA. Adjuvant stereotactic body radiotherapy following transarterial chemoembolization in patients with non-resectable hepatocellular carcinoma tumours of >/= 3 cm. HPB (Oxford). 2015 Feb;17(2):140-9. doi: 10.1111/hpb.12331. Epub 2014 Sep 4.

  PMID: 25186290 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Michael Lock, MD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized to radiation (RT) or TACE plus RT (TACERT)

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 14, 2017
• Study Start: July 31, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: February 24, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: available January 2018
• Access Criteria: No access limitations