Carcinoma, HepatocellularNCT00503867
SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma
A study testing SIR-Spheres microspheres in people with Carcinoma, Hepatocellular and Hepatoma, run by Sirtex Medical at 4 sites in United States.
Trial summary
The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Hepatoma
- What is being tested?
- SIR-Spheres microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Jul 2007to 9 Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- must have a confirmed diagnosis of HCC.
- at least 18 years of age.
- must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 International Units/milliliter (UI/ml).
- must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis.
- must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI).
- must present with a whole-liver tumor burden of greater than or equal to 15% and less than or equal to 70%
- must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- must have normal organ and marrow function
Who cannot join
- Includes both the listed contraindications to SIR-Spheres® and the exclusion criteria specific to the setting of this investigational study:
- hepatic artery directed therapy within the previous 6 months.
- chemotherapy within the previous 4 weeks
- have not recovered from adverse events due to agents administered previously
- Prior external hepatic radiation therapy for HCC, more than two prior systemic chemotherapy regimes for HCC or any other concomitant therapy for HCC
- Currently receiving any other investigational agents for the treatment of their cancer.
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- Any extra-hepatic metastases other than metastatic disease found in the lung, bone and/or abdominal lymph nodes that are not otherwise life limiting.
- Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
- Any of the following contraindications to angiography and selective visceral catheterization:
- Bleeding diathesis
- Severe peripheral vascular disease
- Portal hypertension with hepatofugal flow
- Female subjects who are pregnant or currently breastfeeding.
- Refusal or inability to use effective means of contraception in men or women of childbearing potential.
- Current enrollment in any other investigational drug or device study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
MD Anderson Cancer Center
Houston, Texas, 77030
Thomas Jefferson University - Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
UPMC Liver Cancer Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres®) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma
The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.
Read the detailed description
This study is a multi-institutional, non-randomized pilot study that aims to assess the safety and toxicity of hepatic arterial radioembolization using SIR-Spheres yttrium-90 microspheres (SIR-Spheres microspheres) in the treatment of patients with unresectable primary hepatocellular carcinoma (HCC). The study aims to recruit 40 patients over a period of 24 months.
- Conditions
- Carcinoma, Hepatocellular, Hepatoma
- Being tested
- SIR-Spheres microspheres
- Keywords
- unresectable hepatocellular carcinoma, HCC, SIR-Spheres, Y-90 Microspheres, brachytherapy, Selective Internal Radiation Therapy (SIRT), liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIR-Spheres microspheresDevice
SIR-Spheres Yttrium-90 microspheres
| Study group | Role | What they receive |
|---|---|---|
| SIR-Spheres microspheres | Experimental | SIR-Spheres microspheres Receives: Device: SIR-Spheres microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events Grade 3 or Higher
Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.
Measured: From date of enrollment until the date of death from any cause assessed up 24 weeks.
Secondary outcomes (4)
Time to Disease Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Tumor Response Rate
Tumour response rates estimated by the proportion of patients with a best response of CR, PR or SD by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) with corresponding exact 90% confidence limits being reported. Per RECIST v1.0 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Change From Baseline in Health-related Quality of Life
Measured: 52 weeks
Overall Survival
Overall Survival is defined as the time interval between the date of enrollment and the date of death from any cause.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study start18 Jul 2007
- Primary completion9 Mar 2010
- Study completion9 Mar 2010
Why it stopped: Low patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, HepatocellularStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravi Murthy, MD, Principal investigator, M.D. Anderson Cancer CenterT. Clark Gamblin, MD, Principal investigator, UPMC Liver Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503867
- Sponsor's protocol ID
- STX 0106
- Status last verified
- Nov 2020
- First submitted
- 18 Jul 2007
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Originally there was a plan to share the data with the Data Monitoring Committee, however the study was closed early due to lack of enrollment and the Data Monitoring Committee did not convene.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres®) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00503867
- Acronym / sponsor ID
- STX 0106
- Conditions
- Carcinoma, Hepatocellular, Hepatoma
- Keywords
- unresectable hepatocellular carcinoma, HCC, SIR-Spheres, Y-90 Microspheres, brachytherapy, Selective Internal Radiation Therapy (SIRT), liver cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sirtex MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2007 (actual)
- Primary completion
- 9 Mar 2010 (actual)
- Study completion
- 9 Mar 2010 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.
Detailed description
This study is a multi-institutional, non-randomized pilot study that aims to assess the safety and toxicity of hepatic arterial radioembolization using SIR-Spheres yttrium-90 microspheres (SIR-Spheres microspheres) in the treatment of patients with unresectable primary hepatocellular carcinoma (HCC). The study aims to recruit 40 patients over a period of 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIR-Spheres microspheres | Experimental | Device: SIR-Spheres microspheresSIR-Spheres microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- must have a confirmed diagnosis of HCC.
- at least 18 years of age.
- must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 International Units/milliliter (UI/ml).
- must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis.
- must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI).
Key exclusion criteria (16 listed)
- Includes both the listed contraindications to SIR-Spheres® and the exclusion criteria specific to the setting of this investigational study:
- hepatic artery directed therapy within the previous 6 months.
- chemotherapy within the previous 4 weeks
- have not recovered from adverse events due to agents administered previously
- Prior external hepatic radiation therapy for HCC, more than two prior systemic chemotherapy regimes for HCC or any other concomitant therapy for HCC
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 |
|---|---|---|
| SIR-Spheres microspheresSIR-Spheres Yttrium-90 microspheres | Device | SIR-Spheres microspheres |
Primary outcome
Number of Participants With Adverse Events Grade 3 or Higher
Time frame: From date of enrollment until the date of death from any cause assessed up 24 weeks.
Using the National Cancer Institute Common Terminology Criteria (NCI-CTC) version 3.0 as recorded in the case report form.
4 secondary outcomes
Time to Disease Progression
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Tumor Response Rate
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Change From Baseline in Health-related Quality of Life
Time frame: 52 weeks
Overall Survival
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Originally there was a plan to share the data with the Data Monitoring Committee, however the study was closed early due to lack of enrollment and the Data Monitoring Committee did not convene.
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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.
Ravi Murthy, MD principal investigator
M.D. Anderson Cancer Center
T. Clark Gamblin, MD principal investigator
UPMC Liver Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIR-Spheres microspheres in people with Carcinoma, Hepatocellular and Hepatoma, run by Sirtex Medical at 4 sites 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 8 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: stopped early, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Adverse Events Grade 3 or Higher (time frame: From date of enrollment until the date of death from any cause assessed up 24 weeks.). 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 10 Dec 2020.