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 May 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: May 13, 2014
Last verified: May 2014
  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 Intervention Phase
Liver Cancer
Radiation: yttrium Y 90 glass microspheres
Drug: Cisplatin
Drug: Mitomycin
Drug: Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)

Resource links provided by NLM:


Further study details as provided by Northwestern University:

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.


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.


Estimated Enrollment: 124
Study Start Date: August 2009
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (radioembolization)
Patients undergo radioembolization with yttrium Y 90 glass microspheres by hepatic artery infusion for approximately 1-3 courses.
Radiation: yttrium Y 90 glass microspheres
Patients undergo radioembolization.
Other Name: Radioembolization
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.
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956930

Contacts
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

Locations
United States, Illinois
Northwestern University, Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Carlene del Castillo, RN BSN    312-695-9882    carlene.castillo@northwestern.edu   
Contact: Jennifer Karp, RN BSN    312-926-5289    jkarp@nmff.org   
Sub-Investigator: Laura Kulik, MD         
Sub-Investigator: Robert Lewandowski, MD         
Sub-Investigator: Kent Sato, MD         
Sub-Investigator: Albert Nemcek, MD         
Sub-Investigator: Mary Mulcahy, MD         
Sub-Investigator: Al Benson, MD         
Sub-Investigator: Michael Abecassis, MD         
Sub-Investigator: John Fryer, MD         
Sub-Investigator: Talia Baker, MD         
Sub-Investigator: Ahsun Riaz, MD         
Sub-Investigator: Vanessa Gates, MS, DABR, DABSNM         
Sub-Investigator: Kush Desai, MD         
Sub-Investigator: Ryan Hickey, MD         
Sub-Investigator: Halla Nimeiri, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Riad Salem, MD Northwestern University
  More Information

Additional Information:
No publications provided

Responsible Party: Riad Salem, Chief Vascular and Interventional Radiology, Northwestern University
ClinicalTrials.gov Identifier: NCT00956930     History of Changes
Other Study ID Numbers: STU 12339, P30CA060553, STU# 00012339, CDR0000651416
Study First Received: August 8, 2009
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Northwestern University IRB

Keywords provided by Northwestern University:
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mitomycins
Mitomycin
Doxorubicin
Liposomal doxorubicin
Cisplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Radiation-Sensitizing Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014