Liver TumorsNCT00877136
A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®
An observational study of Liver Tumors and Hepatocellular Carcinoma, run by St. Joseph Hospital of Orange at 1 site in United States.
Trial summary
This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Tumors, Hepatocellular Carcinoma, Hepatoma
- What is being tested?
- TheraSphere®
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2021
- 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 from St. Joseph Hospital of Orange, community members in the St. Joseph Hospital service area and surrounding areas
Who may be able to join
- Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass with known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis)
- Surgical evaluation must conclude the patient is not a candidate for resection or ablation.
- ECOG Performance Status Score 0 - 2.
- Age 18 years or older.
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- Absolute granulocyte count less than or equal to 1,500/ul
- Uncorrected Platelet count less than or equal to 75,000/ul
- Serum creatinine greater than or equal to 3.0 mg/dl
- Serum bilirubin greater than or equal to 2.0 mg/dl
- Any of the following contraindications to angiography and selective visceral catheterization, 1.)History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude catheterization.
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- Portal hypertension with portal venous shunt away from the liver.
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere® administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
- Significant extrahepatic disease representing an imminent life-threatening outcome.
- Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy).
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness.
- Pregnant women may not participate.
- Children may not participate due to lack of clinical experience.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange
Orange, California, 92868
About this study
This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives:
- Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
- Evaluate patient experience and toxicities associated with TheraSphere® treatment.
- Measure tumor response rates
Read the detailed description
The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.
- Conditions
- Liver Tumors, Hepatocellular Carcinoma, Hepatoma, Neoplasms
- Being tested
- TheraSphere®
- Keywords
- Liver tumors, Liver cancer, Adult primary hepatocellular carcinoma, HCC, Hepatoma, Neoplasms
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphere®Device
TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients given access to treatment with TheraSphere.
The number of eligible patients provided with supervised access to treatment with TheraSphere with primary cancer to the liver who are not surgical resection candidates.
Measured: 24 months
Evaluate patient experience with Therasphere.
Evaluation of patient experience and toxicities associated with Therasphere via patient follow-ups with clinician notes.
Measured: 24 months
Secondary outcomes (1)
Tumor response to treatment with TheraSphere®
Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2015
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TumorsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph Hospital of Orange
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Wagman, M.D., F.A.C.S., Principal investigator, St. Joseph Hospital of Orange
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877136
- Sponsor's protocol ID
- 08-029 TheraSphere®
- Status last verified
- Apr 2021
- First submitted
- 3 Apr 2009
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®
- ClinicalTrials.gov ID
- NCT00877136
- Acronym / sponsor ID
- 08-029 TheraSphere®
- Conditions
- Liver Tumors, Hepatocellular Carcinoma, Hepatoma, Neoplasms
- Keywords
- Liver tumors, Liver cancer, Adult primary hepatocellular carcinoma, HCC, Hepatoma, Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- St. Joseph Hospital of OrangeUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 7 Apr 2009 (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.
This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives:
- Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
- Evaluate patient experience and toxicities associated with TheraSphere® treatment.
- Measure tumor response rates
Detailed description
The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from St. Joseph Hospital of Orange, community members in the St. Joseph Hospital service area and surrounding areas
Key inclusion criteria (5 listed)
- Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass with known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis)
- Surgical evaluation must conclude the patient is not a candidate for resection or ablation.
- ECOG Performance Status Score 0 - 2.
- Age 18 years or older.
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
Key exclusion criteria (15 listed)
- Absolute granulocyte count less than or equal to 1,500/ul
- Uncorrected Platelet count less than or equal to 75,000/ul
- Serum creatinine greater than or equal to 3.0 mg/dl
- Serum bilirubin greater than or equal to 2.0 mg/dl
- Any of the following contraindications to angiography and selective visceral catheterization, 1.)History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraSphere®TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue. | Device | – |
Primary outcome
Number of patients given access to treatment with TheraSphere.
Time frame: 24 months
The number of eligible patients provided with supervised access to treatment with TheraSphere with primary cancer to the liver who are not surgical resection candidates.
Evaluate patient experience with Therasphere.
Time frame: 24 months
Evaluation of patient experience and toxicities associated with Therasphere via patient follow-ups with clinician notes.
1 secondary outcome
Tumor response to treatment with TheraSphere®
Time frame: 24 Months
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 6 Apr 2021.
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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.
Lawrence Wagman, M.D., F.A.C.S. principal investigator
St. Joseph Hospital of Orange
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 Tumors and Hepatocellular Carcinoma, run by St. Joseph Hospital of Orange 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?
The sponsor lists 5 inclusion and 15 exclusion criteria. 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 6 Apr 2021. 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?
Number of patients given access to treatment with TheraSphere. (time frame: 24 months). 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?
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 6 Apr 2021.