Liver CancerNCT00739167
Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer
An observational study of Liver Cancer and Metastatic Cancer, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Metastatic Cancer
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
About this study
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)
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.
Read the 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.
- Conditions
- Liver Cancer, Metastatic Cancer
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, liver metastases, recurrent adult primary liver cancer
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Y90 Group | Patients receiving treatment with radioembolization. | |
| TACE Group | Patients receiving treatment with transcatheter arterial embolization | |
| RFA Group | Patients receiving treatment with radiofrequency ablation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of all patients over the course of treatment
Measured: Before treatment, 2 weeks post, and 1 month post
Quality of life differences between treatment groups
Measured: Before treatment, 2 weeks post, and 1 month post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peggy Gilbertsen, RN, BS, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739167
- Sponsor's protocol ID
- NU 07Q1
- Other IDs
- P30CA060553, NU-07Q1, NU-IRB-STU00002799
- Status last verified
- Oct 2015
- First submitted
- 20 Aug 2008
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23644386
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00739167
- Acronym / sponsor ID
- NU 07Q1
- Conditions
- Liver Cancer, Metastatic Cancer
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, liver metastases, recurrent adult primary liver cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Y90 Group | – | –Patients receiving treatment with radioembolization. |
| TACE Group | – | –Patients receiving treatment with transcatheter arterial embolization |
| RFA Group | – | –Patients receiving treatment with radiofrequency ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of hepatocellular carcinoma being treated with either TACE, RFA, or Y90.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life of all patients over the course of treatment
Time frame: Before treatment, 2 weeks post, and 1 month post
Quality of life differences between treatment groups
Time frame: Before treatment, 2 weeks post, and 1 month post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Derived from this study: PubMed 23644386Salem 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy Gilbertsen, RN, BS principal investigator
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Metastatic Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of all patients over the course of treatment (time frame: Before treatment, 2 weeks post, and 1 month post). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.