Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer

NCT ID: NCT00739167

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-05-31

Brief Summary

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RATIONALE: Learning about quality of life in patients with cancer undergoing embolization may help doctors learn about the side effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying quality of life in patients undergoing embolization using yttrium Y 90 glass microspheres for primary or metastatic liver cancer.

Detailed Description

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OBJECTIVES:

Primary

* Assess the quality of life (QOL) as defined by the presence or absence of physical, social, emotional, and functional distress in patients with primary or metastatic liver cancer undergoing treatment with radioembolization or transcatheter arterial embolization.
* Compare the time course of QOL measures between treatment groups in patients treated with these regimens.
* Compare the time course of QOL measures between patient subgroups defined by pre-treatment quality of life or tumor burden.

OUTLINE: Patients complete FACT-Hep version 4 surveys on quality of life prior to initiation of embolization, and at 2 weeks and 1 month after completion of embolization.

Conditions

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Liver Cancer Metastatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Y90 Group

Patients receiving treatment with radioembolization.

No interventions assigned to this group

TACE Group

Patients receiving treatment with transcatheter arterial embolization

No interventions assigned to this group

RFA Group

Patients receiving treatment with radiofrequency ablation.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of primary hepatocellular cancer or metastatic liver cancer
* Planning radioembolization or transcatheter arterial embolization using yttrium Y 90 glass microspheres
* No encephalopathy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Bilirubin ≤ 3 mg/dL
* Able to comply with study procedures

PRIOR CONCURRENT THERAPY:

* No prior treatment with radioembolization or transcatheter arterial embolization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peggy Gilbertsen, RN, BS

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

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Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Salem R, Gilbertsen M, Butt Z, Memon K, Vouche M, Hickey R, Baker T, Abecassis MM, Atassi R, Riaz A, Cella D, Burns JL, Ganger D, Benson AB 3rd, Mulcahy MF, Kulik L, Lewandowski R. Increased quality of life among hepatocellular carcinoma patients treated with radioembolization, compared with chemoembolization. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1358-1365.e1. doi: 10.1016/j.cgh.2013.04.028. Epub 2013 May 2.

Reference Type DERIVED
PMID: 23644386 (View on PubMed)

Other Identifiers

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P30CA060553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NU-07Q1

Identifier Type: -

Identifier Source: secondary_id

NU-IRB-STU00002799

Identifier Type: -

Identifier Source: secondary_id

NU 07Q1

Identifier Type: -

Identifier Source: org_study_id

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