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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Riad Salem, Northwestern University
ClinicalTrials.gov Identifier:
NCT00956930
First received: August 8, 2009
Last updated: November 11, 2014
Last verified: November 2014

August 8, 2009
November 11, 2014
August 2009
August 2016   (final data collection date for primary outcome measure)
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.
  • Response rate at 6 months in patients with ablatable disease [ Designated as safety issue: No ]
  • Time to progression in patients with non-ablatable disease [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00956930 on ClinicalTrials.gov Archive Site
  • 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.
  • Comparison of biochemical and radiological parameters [ Designated as safety issue: No ]
  • Comparison of pre-post changes in biomarkers [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery
An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
  • Radiation: yttrium Y 90 glass microspheres
    Patients undergo radioembolization.
    Other Name: Radioembolization
  • Drug: 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)
  • Experimental: Arm I (radioembolization)
    Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
    Intervention: Radiation: yttrium Y 90 glass microspheres
  • 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.
    Interventions:
    • Drug: Cisplatin
    • Drug: Mitomycin
    • Drug: Doxorubicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
August 2018
August 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Riad Salem, MD, MBA 312-695-6371 r-salem@northwestern.edu
Contact: Carlene del Castillo, RN BSN 312-695-9882 carlene.castillo@northwestern.edu
United States
 
NCT00956930
STU 12339, P30CA060553, STU# 00012339, CDR0000651416
Yes
Riad Salem, Northwestern University
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: Riad Salem, MD Northwestern University
Northwestern University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP