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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), December 2008

First Received: August 20, 2008 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00739167

Purpose

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.

Condition	Intervention
Liver Cancer Metastatic Cancer	Other: survey administration Procedure: quality-of-life assessment Radiation: yttrium Y 90 glass microspheres

MedlinePlus related topics: Cancer Eye Wear Liver Cancer Methamphetamine

Drug Information available for: Methamphetamine hydrochloride TheraSphere Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Quality of Life Study for Patients With Primary or Metastatic Liver Cancer Who Are Treated With Radioembolization (Y90 Microspheres) or Transcatheter Arterial Embolization (TACE)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Quality of life as measured by the FACT-Hep version 4 survey on quality of life [ Designated as safety issue: No ]
Change in quality of life over time [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739167

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Peggy Gilbertsen, RN, BS

Robert H. Lurie Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000593553, NU-07Q1, NU-IRB-STU00002799
Study First Received:	August 20, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00739167 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult primary hepatocellular carcinoma
advanced adult primary liver cancer
liver metastases
recurrent adult primary liver cancer

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Quality of Life
Recurrence
Carcinoma
Liver Neoplasms

Methamphetamine
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Amphetamine
Hepatocellular Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Neoplastic Processes
Liver Diseases
Neoplasms
Pathologic Processes

Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasm Metastasis

ClinicalTrials.gov processed this record on May 06, 2009