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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients are candidates to receive both proton beam and TACE
Patients with no evidence of metastasis or macrovascular invasion
Patients with tumor burden that meets San Francisco criteria

Exclusion criteria

Patients who are candidates for surgical resection
Patients with lesion < 2 cm
Patients who have contraindication to receive either TACE or proton
Patients with serum alpha fetoprotein > 500
Patients with metastasis or macrovascular invasion
Patients treated previously for HCC by any locoregional treatment
Patients with prior liver transplant
Patients with Child class C
Patients with MELD score of > 25
Patients with other comorbid diseases that may impact survival
Patients with ongoing alcohol intake
Patients with active sepsis
Patients with gastrointestinal bleeding within a week
Patients unwilling to sign informed consent form
Patients with history of noncompliance

Treatment and study plan

Transarterial chemoembolization

Procedure

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

Other names: (TACE)

Proton Beam Radiotherapy

Radiation

Fifteen consecutive sessions

Primary outcomes

Two Year Overall Survival

Time frame: 24 Months

Comparison between arms of the percentage of patient alive 2 years following study treatment.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2021
Study completion: 2021
First posted: Mar 9, 2009
Registry last updated: May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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