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SBRT vs TACE as Bridge to Transplant for Liver Cancer (SBRTvsTACE Trial)

Phase 3

Waitlist Available

Led By Corrine Zarwan, MD

Research Sponsored by Lahey Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be 18 years of age or older. Adult subjects of all ages, both sexes and all races will be included in this study.

Subjects must be within UCSF criteria (one solitary tumor smaller than 6.5 cm, or patients having 3 or fewer nodules, with the largest lesion being smaller than 4.5 cm or having a total tumor diameter less than 8.5 cm without vascular invasion) and eligible for potential liver transplant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post treatment

Awards & highlights

SBRTvsTACE Trial Summary

This trial will compare two cancer treatments, SBRT and TACE, to see which one keeps cancer at bay longer in patients with HCC who are undergoing liver transplantation.

Who is the study for?

This trial is for adults with Hepatocellular Carcinoma (HCC) who are candidates for liver transplantation. They must meet specific criteria including having a tumor within certain size limits, good organ function, and no history of prior radiation to the liver or evidence of metastatic disease. Pregnant women, individuals under 18, and those with severe allergies to contrast agents or refractory ascites are excluded.Check my eligibility

What is being tested?

The study compares Stereotactic Body Radiation Therapy (SBRT) and Trans-Arterial Chemoembolization (TACE), using Doxorubicin as a bridge treatment before liver transplant in HCC patients. It aims to determine if SBRT leads to longer intervals without needing retreatment compared to TACE.See study design

What are the potential side effects?

Potential side effects include damage to surrounding organs from radiation (SBRT), chemical-related side effects like nausea and hair loss from Doxorubicin used in TACE, allergic reactions to contrast agents used during imaging studies, and general risks associated with invasive procedures.

SBRTvsTACE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My liver cancer fits specific size criteria and I could be eligible for a transplant.

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My liver cancer diagnosis was confirmed by a biopsy or meets specific imaging criteria.

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My kidney function tests are within normal limits.

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My healthy liver volume is more than 700ml.

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I have liver cancer confirmed by biopsy or specific imaging criteria.

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I am eligible for TACE or SBRT treatments according to standard care.

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My bilirubin level is below 3.0 mg/dl, and I don't have a bile duct condition.

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I can take care of myself but might not be able to do heavy physical work.

SBRTvsTACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease

Secondary outcome measures

Number of further interventions

Rate of pathological response of treated lesion(s)

Rate of radiological response of treated lesion(s)

+5 more

SBRTvsTACE Trial Design

2Treatment groups

Experimental Treatment

Group I: Trans-Arterial Chemoembolization (TACE)Experimental Treatment2 Interventions

Procedure/Surgery - Chemoembolization Drug: Doxorubin

Group II: Stereotactic Body Radiation Therapy (SBRT)Experimental Treatment1 Intervention

Radiation Therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubin

2014

Completed Phase 2

~60

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~740

Trans-Arterial Chemoembolization (TACE)

2014

Completed Phase 2

~60

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Varian Medical SystemsIndustry Sponsor

58 Previous Clinical Trials

3,543 Total Patients Enrolled

1 Trials studying Liver Cancer

18 Patients Enrolled for Liver Cancer

Merit Medical Systems, Inc.Industry Sponsor

30 Previous Clinical Trials

3,459 Total Patients Enrolled

Lahey ClinicLead Sponsor

72 Previous Clinical Trials

245,049 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (SBRT) Clinical Trial Eligibility Overview. Trial Name: NCT03960008 — Phase 3

Liver Cancer Research Study Groups: Trans-Arterial Chemoembolization (TACE), Stereotactic Body Radiation Therapy (SBRT)

Liver Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT03960008 — Phase 3

Stereotactic Body Radiation Therapy (SBRT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03960008 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this particular medication been authorized by the FDA?

"This treatment received a 3 on our safety scale at Power. This is because it is a Phase 3 trial, indicating that while there is some efficacy data, there is strong safety data from multiple rounds of testing."

Answered by AI

Can you tell me how many places are running this trial?

"So far, 5 hospitals are running this trial, these include The Ohio State University Comprehensive Cancer Center, Lahey Hospital & Medical Center, and Princess Margaret Hospital, UHN."

Answered by AI

Are there any patients who can still sign up for this clinical trial?

"The clinicaltrials.gov website informs us that this study is not looking for participants at this time. This study was posted on March 1st, 2020 and was last updated on October 26th, 2020. There are 3070 other studies that are presently looking for patients."

Answered by AI

Do the findings of this research stand alone, or have they been corroborated by other investigations?

"The first recorded study of this intervention was at Spectrum Health Hospital - Butterworth Campus in 1997. So far, there have been 684 completed studies with 380 more currently underway. A large number of these ongoing trials are based in Columbus, Ohio."

Answered by AI

Is this the initial clinical trial of this medication?

"Alfacell first sponsored a clinical trial for this treatment in 1997, which involved 300 patients. Since the initial trial, there have been 380 active studies in 1929 cities and 67 countries."

Answered by AI

What are the most popular issues that this medication helps with?

"This therapy is commonly used to treat Hodgkin's lymphoma but can also be useful in treating other conditions such as carcinoma, bronchogenic, neuroblastoma (NB), and Sezary syndrome."

Answered by AI

What is the total number of individuals participating in this clinical trial?

"This particular research study is not currently enrolling patients. The trial was first posted on March 1st, 2020 and was most recently edited on October 26th, 2022. If you are seeking other studies, 2690 clinical trials for liver carcinoma and 380 for this treatment are actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant

2020. "Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03960008.

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