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

Metastatic Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739167
• Other study ID #: NU 07Q1
• Secondary ID: P30CA060553NU-07
• Status: Completed
• Phase: N/A
• First received: August 20, 2008
• Last updated: October 14, 2015
• Start date: April 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life of all patients over the course of treatment		Before treatment, 2 weeks post, and 1 month post	No
Primary	Quality of life differences between treatment groups		Before treatment, 2 weeks post, and 1 month post	No