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An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

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Trial Information

An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression in patients treated with TACE and Y90

Outcome Description:

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.

Outcome Time Frame:

up to 6 yrs

Safety Issue:

No

Principal Investigator

Riad Salem, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Food and Drug Administration

Study ID:

STU 12339

NCT ID:

NCT00956930

Start Date:

August 2009

Completion Date:

August 2018

Related Keywords:

  • Liver Cancer
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Northwestern University, Northwestern Memorial HospitalChicago, Illinois  60611-3013