Stage III Hepatocellular Carcinoma AJCC v8NCT01176604
Yttrium Y 90 Glass Microspheres in Treating Patients With Unresectable Hepatocellular Carcinoma
A study testing Yttrium Y 90 Glass Microspheres in people with Stage III Hepatocellular Carcinoma AJCC v8 and Stage IIIA Hepatocellular Carcinoma AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8
- What is being tested?
- Yttrium Y 90 Glass Microspheres
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2010to 9 Apr 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of intrahepatic HCC. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alphafetoprotein (AFP) and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
- Life expectancy >= 3 months
- > 4 weeks since prior radiation, surgery or chemotherapy
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Who cannot join
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper normal limit (UNL) (within 15 days of treatment demonstrating liver dysfunction)
- Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned) (within 15 days of treatment demonstrating liver dysfunction)
- Any contraindications to angiography and hepatic artery catheterization such as:
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
- Bleeding diathesis, not correctable by usual forms of therapy
- Severe peripheral vascular disease that would preclude catheterization
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- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
- Clinical evidence of pulmonary insufficiency
- Evidence of any detectable technetium-99 macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow
- Complete occlusion of the main portal vein
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
- Pregnancy
- Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma
This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Provide oversight to treatment with yttrium Y 90 glass microspheres (TheraSphere) to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.
II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
OUTLINE:
Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-6 weeks, then annually for up to 2 years.
- Conditions
- Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8
- Being tested
- Yttrium Y 90 Glass Microspheres
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium Y 90 Glass MicrospheresRadiation
Also called TheraSphere
Given via catheter
| Study group | Role | What they receive |
|---|---|---|
| Treatment (yttrium Y 90 glass microspheres) | Experimental | Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity. Receives: Radiation: Yttrium Y 90 Glass Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oversight to treatment with yttrium Y 90 glass microspheres
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Measured: Up to 2 years
Patient experience
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Measured: Up to 2 years
Incidence of adverse events
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Measured: 30 days after each treatment
Overall survival
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study start4 Aug 2010
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Hepatocellular Carcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Armeen Mahvash, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176604
- Sponsor's protocol ID
- 2008-0770
- Other IDs
- NCI-2018-01816, 2008-0770, P30CA016672
- Status last verified
- Oct 2022
- First submitted
- 4 Aug 2010
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Humanitarian Device Exemption Treatment Protocol of TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01176604
- Acronym / sponsor ID
- 2008-0770
- Conditions
- Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Aug 2010 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 6 Aug 2010 (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 trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.
Detailed description
PRIMARY OBJECTIVES:
- Provide oversight to treatment with yttrium Y 90 glass microspheres (TheraSphere) to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.
II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
OUTLINE:
Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-6 weeks, then annually for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (yttrium Y 90 glass microspheres) | Experimental | Radiation: Yttrium Y 90 Glass MicrospheresPatients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of intrahepatic HCC. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alphafetoprotein (AFP) and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
- Life expectancy >= 3 months
- > 4 weeks since prior radiation, surgery or chemotherapy
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Key exclusion criteria (16 listed)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper normal limit (UNL) (within 15 days of treatment demonstrating liver dysfunction)
- Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned) (within 15 days of treatment demonstrating liver dysfunction)
- Any contraindications to angiography and hepatic artery catheterization such as:
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
- Clinical evidence of pulmonary insufficiency
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 |
|---|---|---|
| Yttrium Y 90 Glass MicrospheresAlso: TheraSphereGiven via catheter | Radiation | Treatment (yttrium Y 90 glass microspheres) |
Primary outcome
Oversight to treatment with yttrium Y 90 glass microspheres
Time frame: Up to 2 years
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Patient experience
Time frame: Up to 2 years
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Incidence of adverse events
Time frame: 30 days after each treatment
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
Overall survival
Time frame: Up to 2 years
Associated with yttrium Y 90 glass microspheres treatment. Data analysis will be limited to descriptive reports of the number and characteristics of the patients treated and their clinical and adverse event experiences.
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 14 Oct 2022.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Armeen Mahvash principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yttrium Y 90 Glass Microspheres in people with Stage III Hepatocellular Carcinoma AJCC v8 and Stage IIIA Hepatocellular Carcinoma AJCC v8, run by M.D. Anderson Cancer Center 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 16 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 14 Oct 2022. 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?
Oversight to treatment with yttrium Y 90 glass microspheres (time frame: Up to 2 years). The study lists 4 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 14 Oct 2022.