Randomized Phase III Clinical Trial of Stereotactic Body Radiation Therapy versus Transarterial Chemoembolization in Hepatocellular Carcinoma

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Open for proposals

Project Type

Coordinated Research Project

Project Code

E33036

CRP

1998

Approved Date

2013/09/13

Status

3 - Active - Ongoing

Start Date

2014/05/29

Expected End Date

2021/05/28

Participating Countries

Australia
Brazil
China
Denmark
Egypt
India
Indonesia
Netherlands
Republic of Korea
Thailand
United States of America

Description

Hepatocellular carcinoma (HCC) is a major health problem worldwide: it is the sixth most common cancer and the third most common cause of cancer death. Eighty-five percent of cases occur in developing countries (largely in Asia and Africa), while in the USA it is the fastest growing cancer. Risk factors for HCC include hepatitis B, hepatitis C, alcohol ingestion and cirrhosis from any cause. The majority of cases are found in countries with endemic hepatitis B. Chronic hepatitis C viral infection is a leading cause of HCC in Europe, Japan, and North America. Surgical resection, an option for a minority of tumours (less than 20% of cases), results in five-year survival rates of 60% to 70%. Liver transplantation can cure both the cancer and underlying liver disease in highly selected cases only. As an alternative to surgery, percutaneous or laparoscopic radio frequency ablation or alcohol injection may be used as curative therapy for early HCC. For unresectable HCC that is unsuitable for ablative therapies, transarterial chemoembolization (TACE) has a survival advantage as compared to best supportive care. Stereotactic body radiotherapy (SBRT), an emerging treatment method that enables high precision and high dose delivery to the tumour using a small number of fractions, has a capacity to serve as a potent cytoreductive intervention offering potentially curative therapy or potentially valuable salvage therapy for many tumour types, including all stages of HCC. The emerging data indicate that SBRT compares favourably with other ablative procedures for HCC in terms of local control, safety and survival. The role of SBRT versus other treatments for HCC warrants further investigation. This CRP proposes to evaluate the precise role of SBRT in the management of unresectable HCCs in comparison with TACE, in a prospective randomized setting. It is expected that the results of this CRP will have a worldwide impact, and that they will be particularly relevant for developing countries mainly in Asia and Africa where the disease is common.

Objectives

To demonstrate equivalence /superiority of SBRT given upfront over TACE in terms of any disease progression in previously untreated patients with HCC.

Specific objectives

To assess early and late toxicity of SBRT in the treatment of HCC

To asses the effectiveness (response rate, local failure rate, extra-hepatic failure, survival, quality of life) of SBRT in the treatment of HCC compared to TACE.

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Progression at 1 year: local, intra- and extrahepatic progression, Response rate, Local failure, Overall survival, toxicity, Quality of life assessment (EORTC QLQC30, EORTC QLQ-HCC18) and Cost Benefit analysis.

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