CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
Transarterial Chemoembolization +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00857805
NCT00857805N/ACompleted

Randomized Controlled Trial of Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma

Loma Linda University·interventional·Posted Mar 9, 2009·Updated May 31, 2024

In Brief

A clinical study evaluating Transarterial Chemoembolization and Proton Beam Radiotherapy for Carcinoma, Hepatocellular. Completed, enrolled 76 participants across 1 site.

Detailed Summary

Patients with liver tumor burden that exceeds Milan criteria are considered to receive one of the following locoregional treatments: transarterial chemoembolization (TACE), radiofrequency ablation (RFA), percutaneous ethanol injection and proton beam radiation (PBR). The goals of these treatments are to control tumor growth, to downstage tumor size to meet Milan criteria, and to improve survival. Patients who exceed the Milan criteria benefit from tumor downstaging as a result of treatment. Patients who meet Milan criteria benefit from tumor control to bridge them to liver transplantation. TACE is considered the most common locoregional treatment that is used to treat hepatocellular carcinoma (HCC). Proton beam radiotherapy has been used in treating HCC in a few centers across the globe. Phase I and II trials showed a satisfactory safety and efficacy results. Loma Linda University Medical Center is one of these pioneering centers that use proton beam as a treatment for HCC. This is the first randomized trial in the medical field that will compare head-to-head the efficacy of TACE versus proton beam in treating HCC patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2009
Enrollment StartJan 7, 2009
Primary CompletionJul 7, 2021
TodayJul 2, 2026
Enrollment to primary: 12.5 yearsPosted 17.3 years ago

Interventions

Transarterial Chemoembolizationprocedure

Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.

Proton Beam Radiotherapyradiation

Fifteen consecutive sessions