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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00892658 |
Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. The incidence is highest in Asia and it is increasing in North America, with a two to three fold increase in mortality in North America expected over the next two decades. Previous research has shown that tumours often have abnormal blood vessels that may reduce the effect of radiation therapy. New drugs, known as "anti-angiogenic" drugs have been shown in animal and human studies to damage or change tumour blood vessels in ways that may make tumors more sensitive to radiation treatment. 38-44 patients diagnosed with HCC will be invited to take part in this study. Upon completion, this study will establish the safety of the combination of radiation and sorafenib in patients with HCC. This will also establish preliminary data regarding efficacy of the combination and investigate potential imaging and serum/tissue markers surrogates for tumor response and/or drug activity.
Condition | Intervention | Phase |
---|---|---|
Hepatocellular Carcinoma |
Drug: Sorafenib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Sorafenib and Radiation Therapy in Patients With Hepatocellular Carcinoma |
Estimated Enrollment: | 44 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2015 |
Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
As part of this study, patients will receive sorafenib alone (at escalating doses following the dose escalation scheme) for one week, followed by 2 weeks of concurrent administration of sorafenib with conformal radiation therapy (6 fractions over two weeks). Sorafenib administration will continue for four weeks following completion of radiation, at the study dose. At three months following radiation, when liver toxicity is assessed and is absent, full dose sorafenib (400mg PO BID) will then be initiated and continued until disease progression or serious toxicity occurs, to a maximum time of 12 months.
The study design will include 2 radiation strata of patients, with a constant radiation dose for strata 1 requiring a low volume of liver to be irradiated, and a variable dose defined based on the effective liver volume irradiated in the second strata, which will require more liver volume to be irradiated, based on our prior experience. The first strata will be planned to be completed prior to the second strata. Biologic response will be assessed using standard contrast CT scans. Correlative studies of biological markers, perfusion CT, and microbubble contrast enhanced ultrasound will also be performed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have HCC either
Exclusion Criteria:
Contact: Laura Dawson, MD | 416 946 4501 ext 2125 | laura.dawson@rmp.uhn.on.ca |
Canada, Ontario | |
University Health Network | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Laura Dawson, MD 416 946 4501 ext 2125 laura.dawson@rmp.uhn.on.ca | |
Principal Investigator: Laura Dawson, MD |
Principal Investigator: | Laura Dawson, MD | University Health Network, Princess Margaret Hospital |
Responsible Party: | University Health Network, Research Ethics Board ( Dr. Laura Dawson, Staff Radiation Oncology, Clinician Scientist ) |
Study ID Numbers: | UHN REB 08-0761-C |
Study First Received: | May 1, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892658 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Sorafenib Hepatocellular carcinoma |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Gastrointestinal Neoplasms |
Hepatocellular Carcinoma Adenocarcinoma Protein Kinase Inhibitors Sorafenib Neoplasms, Glandular and Epithelial Carcinoma |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Hepatocellular Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |