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

NCT00739167 | Completed DMC

• 4 other identifiers: NU 07Q1P30CA060553NU-07Q1NU-IRB-STU00002799
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cancer; Metastatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Quality of life of all patients over the course of treatment

  Before treatment, 2 weeks post, and 1 month post

• Quality of life differences between treatment groups

  Before treatment, 2 weeks post, and 1 month post

Study Arms (3)

Y90 Group

Patients receiving treatment with radioembolization.

TACE Group

Patients receiving treatment with transcatheter arterial embolization

RFA Group

Patients receiving treatment with radiofrequency ablation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of hepatocellular carcinoma being treated with either TACE, RFA, or Y90.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Related Publications (1)

• 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.

  PMID: 23644386 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Peggy Gilbertsen, RN, BS

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 16, 2015

Record last verified: 2015-10

Locations

US (1)