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

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	Drug: yttrium Y 90 glass microspheres Procedure: quality-of-life assessment Procedure: survey administration

MedlinePlus related topics:

Cancer Eye Wear Liver Cancer

ChemIDplus related topics:

TheraSphere

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

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

Study ID Numbers:	CDR0000593553, NU-07Q1, NU-IRB-STU00002799
First Received:	August 20, 2008
Last Updated:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00739167
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 Neoplasms

Liver Diseases

Digestive System Diseases

Digestive System Neoplasms

Carcinoma, Hepatocellular

Liver neoplasms

Neoplasm Metastasis

Quality of Life

Gastrointestinal Neoplasms

Recurrence

Hepatocellular carcinoma

Carcinoma

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Pathologic Processes

Neoplasms by Site

ClinicalTrials.gov processed this record on October 15, 2008

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