RecruitingPhase 3NCT03895359

Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Liver Carcinoma

A Phase III Randomized Trial of Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Primary or Secondary Liver Carcinoma

Sponsor

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

Enrollment

128 participants

Start Date

May 27, 2019

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

Summary

Trans-arterial chemoembolization (TACE) is a standard treatment for patients with hepatocellular carcinoma (also called liver cancer). This is where chemotherapy is injected into the arteries of the liver and liver cancer. Unfortunately, the tumour grows after TACE in many patients. A new treatment using a specialized radiation procedure called Stereotactic ablative body radiotherapy (SBRT) may increase the chance to control liver cancer. SBRT allows radiation treatments to be focused more precisely, and be delivered more accurately than with older treatments. The purpose of this study is to find out if TACE alone versus TACE plus SBRT is better for you and your liver cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to treating liver tumors: TACE alone — a procedure that delivers chemotherapy directly into tumors via a catheter while cutting off their blood supply — versus TACE combined with targeted radiation therapy (SBRT). The goal is to determine whether adding radiation improves tumor control and survival. **You may be eligible if...** - You have primary liver cancer or cancer that has spread to the liver from another cancer - You have 5 or fewer measurable liver tumors, each 25 cm or smaller - You have not had prior liver-directed treatment, or your liver tumors are newly progressing - Your overall health allows for these procedures **You may NOT be eligible if...** - You have already received prior radiation that overlaps with the planned treatment area - Your liver function is too poor to tolerate treatment - You are pregnant - You have conditions preventing safe completion of TACE or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiation

For patients randomized to the SMRT arm, SBRT is to be delivered over 5 fractions delivered over 5 to 15 days.

DRUGTransarterial Chemoembolization

Transarterial chemoembolization is a standard treatment for patients with hepatocellular carcinoma (liver cancer). Chemotherapy is injected into the arteries of the liver and liver cancer.