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Spots Global Cancer Trial Database for Study to Compare Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (HCC)

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Pierce KH Chow, MBBS, PhD

Affiliation: National Cancer Centre, Singapore

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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