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

NCT03079778 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-02-24

No results posted yet for this study

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

Interventions

PROCEDURE

transarterial chemoembolization

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

RADIATION

TACE plus RT

radiobiologically guided radiation

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Michael Lock, MD · University of Western Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2022-08-31
Completion
2023-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03079778 on ClinicalTrials.gov