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Brief Title: Study to Compare Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (HCC)
Official Title: Phase III Multi-Centre Open-Label Randomized Controlled Trial of Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (SIRveNIB)
Study ID: NCT01135056
Brief Summary: The primary objective of this study is to assess the efficacy of SIRT as compared with Sorafenib in patients with locally advanced liver cancer in terms of overall survival (OS). The Study null hypothesis is, there is no difference in overall survival between patients receiving SIRT and those receiving Sorafenib therapy.
Detailed Description: Hepatocellular carcinoma (HCC) is the 5th most common cancer worldwide but unfortunately between 70 - 80% of all HCC are in the Asia-Pacific because of the prevalence of chronic viral hepatitis in the region. The increase in the prevalence of chronic hepatitis C in the Western world however predicts that HCC will similarly be an important cause of death there in the next 20 years. Only 15-20% of HCC are today potentially curable by surgery at the time of diagnosis. Another 10-15% of patients may benefit from potentially curative locally ablative therapy such as radio-frequency ablation. Prognosis in the majority of patients has been dismal as conventional systemic therapies have been largely inefficacious. The first successfully trialed systemic targeted therapy, sorafenib (2007) prolonged survival by a modest average of 3 months in patients with good underlying liver function. While the liver is radio-sensitive, external beam radiation causes significant radio-toxicity. To overcome this, selective internal radiation therapy (SIRT) was developed to deliver a radiation source directly to liver cancer via the arterial route. Sir-sphere is radioactive yttrium on a 90 micro-meter diameter resin carrier and is an established therapy in colorectal metastasis. Sir-sphere has been reported to cause significantly tumour regression in HCC. This study will evaluate the efficacy of SIRT using SIR-Spheres yttrium-90 microspheres compared to sorafenib in the treatment of patients with locally advanced primary HCC.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Brunei Cancer Centre, Jerudong, Brunei, Brunei Darussalam
Queen Mary Hospital, Hong Kong, Hong Kong, China
University of Udayana, Rumah Sakit Sanglah, Indonesia, Denpasar, Bali, Indonesia
Cipto Mangunkusumo Hospital ,University of Indonesia, Jakarta, , Indonesia
Severance Hospital, Yonsei University College of Medicine, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Bundang Hospital, Seoul, , Korea, Republic of
Sarawak General Hospital, Kuching, Sarawak, Malaysia
University Malaya Medical Center, Kuala Lumpur, , Malaysia
Penang Adventist Hospital, Penang, , Malaysia
National Cancer Center of Mongolia, Ulaanbaatar, , Mongolia
Yangon GI & Liver Centre, Yangon, , Myanmar
Auckland City Hospital, Grafton, Auckland, New Zealand
Makati Medical Center, Manila, Makati City, Philippines
The Medical City, Pasig City, Manila, Philippines
St. Luke's Medical Center, Philippines, Quezon City, Manila, Philippines
Davao Doctors Hospital, Davao, , Philippines
National University Hospital, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Khoo Teck Puat Hospital, Singapore, , Singapore
National Taiwan University Hospital, Taipei City, Taipei, Taiwan
Taipei Veterans General Hospital, Taipei City, Taipei, Taiwan
Chang Gung Memorial Hospital, Taoyuan, Taoyuan Hsien, Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Chulabhorn Hospital, Bangkok, , Thailand
Name: Pierce KH Chow, MBBS, PhD
Affiliation: National Cancer Centre, Singapore
Role: STUDY_CHAIR