Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery | RxWiki

Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery

Overview[ - collapse ][ - ]

Purpose	RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet known which treatment regimen is more effective in treating patients with liver cancer. PURPOSE: This randomized phase II trial is studying radioembolization to see how well it works compared with chemoembolization in treating patients with liver cancer that cannot be treated with Radiofrequency Ablation or removed by surgery.
Condition	Liver Cancer
Intervention	Radiation: yttrium Y 90 glass microspheres Drug: Cisplatin Drug: Mitomycin Drug: Doxorubicin
Phase	Phase 2
Sponsor	Northwestern University
Responsible Party	Northwestern University
ClinicalTrials.gov Identifier	NCT00956930
First Received	August 8, 2009
Last Updated	March 5, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	August 8, 2009
Last Updated Date	March 5, 2014
Start Date	August 2009
Estimated Primary Completion Date	August 2018
Current Primary Outcome Measures	Time to progression in patients treated with TACE and Y90 [Time Frame: up to 6 yrs] [Designated as safety issue: No]Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression. They have repeat imaging done (MRI or CT) 1 month post procedure and then every 3 months after that.
Current Secondary Outcome Measures	Characterize the safety and toxicity profile of these regimens [Time Frame: up to 6 years] [Designated as safety issue: Yes]After treatment toxicities are evaluated in patients at 2 weeks, 4 weeks, and then every 3 months post-treatment. Determine tumor response and the need for subsequent treatment in these patients [Time Frame: up to 6 years] [Designated as safety issue: No]Repeat imaging (CT/MRI) and lab work including tumor markers will be assessed 1 month post-treatment then every 3 months after that. Characterize change in quality of life and performance status in these patients [Time Frame: up to 6 years] [Designated as safety issue: Yes]Subjects complete a Fact-Hep quality of life questionnaire pre-treatment, 1 month post-treatment and then every three months post-treatment. Performance status is evaluated pre-treatment, 1 month and then every 3 months post-treatment.

Descriptive Information[ + expand ][ + ]

Brief Title	Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery
Official Title	An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)
Brief Summary	RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet known which treatment regimen is more effective in treating patients with liver cancer. PURPOSE: This randomized phase II trial is studying radioembolization to see how well it works compared with chemoembolization in treating patients with liver cancer that cannot be treated with Radiofrequency Ablation or removed by surgery.
Detailed Description	OBJECTIVES: Primary - Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression. Secondary - Characterize the safety and toxicity profile of these regimens. - Determine the need for subsequent treatment in these patients. - Determine tumor response in these patients - Characterize change in quality of life and functional status in these patients. - Determine time to progression in these patients. OUTLINE: Patients are randomized to receive either TACE or Y90 - Arm I (radioembolization): Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. - Arm II (transarterial chemoembolization [TACE]): Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses. - In both arms, treatment modifications may apply according to response. After completion of study treatment, patients are followed every 3 months.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Liver Cancer
Intervention	Radiation: yttrium Y 90 glass microspheres Patients undergo radioembolization. Other Names: RadioembolizationDrug: Cisplatin 100mg fixed dose Other Names: Platinol Chemoembolization (TACE) Drug: Mitomycin 30mg Fixed dose Other Names: Mitomycin C Mutamycin Mitozytrex Chemoembolization (TACE) Drug: Doxorubicin 30mg fixed dose Other Names: Doxorubicin hydrocholoride Adriamycin Chemoembolization (TACE)
Study Arm (s)	Experimental: Arm I (radioembolization) Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses. Experimental: Arm II (transarterial chemoembolization [TACE]) Patients undergo TACE with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	124
Estimated Completion Date	August 2018
Estimated Primary Completion Date	August 2016
Eligibility Criteria	DISEASE CHARACTERISTICS: - Hepatocellular Carcinoma confined to the liver that is unresectable with surgery or unable to be treated with radiofrequency ablation diagnosed by biopsy or imaging criteria (CT/MRI) - No segmental, lobar, or main portal vein thrombosis as evidenced by CT or MRI imaging PATIENT CHARACTERISTICS: - Able to carry out activities of daily living, awake > 50% or waking hours - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No severe cardiac disease - No active clinically serious infection - No psychological or physical condition or substance use/abuse that, in the opinion of the principal investigator or a sub-investigator, would possibly endanger the patient during study participation or allow for non-compliance with study treatment PRIOR CONCURRENT THERAPY: - Prior liver resection allowed - No prior systemic, ablative, or infusion therapy - More than 4 weeks since prior major surgery - Concurrent anticoagulation allowed provided there is documentation that no coagulation abnormality existed prior to use of anticoagulants
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Riad Salem, MD, MBA 312-695-6371 r-salem@northwestern.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00956930
Other Study ID Numbers	STU 12339
Has Data Monitoring Committee	Yes
Information Provided By	Northwestern University
Study Sponsor	Northwestern University
Collaborators	National Cancer Institute (NCI)
Investigators	Principal Investigator: Riad Salem, MD Northwestern University
Verification Date	March 2014

Locations[ + expand ][ + ]

Northwestern University, Northwestern Memorial Hospital	Chicago, Illinois, United States, 60611-3013 Contact: Jacquelyn Powell-Johnson, RN BSN \| 312-695-4023 \| jpowell@nmff.org Sub-Investigator: Laura Kulik, MD Recruiting