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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


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
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