CholangiocarcinomaNCT01253148
Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma
A study testing TheraSphere® Yttrium-90 (Y-90) Microspheres in people with Cholangiocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to see if Therasphere will be a better way to treat cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this treatment will have on the patient and their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- TheraSphere® Yttrium-90 (Y-90) Microspheres
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2015
- 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
- Patients must have newly diagnosed or recurrent (post surgery) histologically or cytologically proven cholangiocarcinoma.
- Patients can have solitary, multifocal unilobar, or bilobar disease without evidence of extrahepatic involvement. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI).
- Age >18 years
- Life expectancy of greater than 3 months based on physician judgment
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 (Karnofsky 50%)
- No prior chemotherapy or radiation treatment for cholangiocarcinoma
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- Childs-Pugh score A or Childs-Pugh score B without portal vein thrombus
- Lung shunting that predicts lung dose to be <30 Gy in a single treatment
- The effects of TheraSpheres on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radioactive spheres are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
- Adequate baseline hematopoietic function:
- total white blood cell count equal to or greater than 3,000/mm³
- absolute granulocyte count greater than 1,500/mm³
- platelet count equal to or greater than 100,000/mm³
- Hemoglobin >8.0
Who cannot join
- Patients receiving any other investigational agents
- Patients with extrahepatic disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because TheraSpheres are radioactive and radiation is a known agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSpheres, breastfeeding should be discontinued if the mother is treated with TheraSpheres.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. In addition, antiretrovirals are known radiation sensitizers and could dramatically increase the risk of fulminant hepatic failure. Therefore, HIV-positive patients are excluded from the study because of possible lethal side effects.
- Bulk disease (tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count)
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- Aspartic transaminase (AST) or alanine transaminase (ALT) > 5 times upper limit of normal (ULN)
- Bilirubin > 2 mg/dL
- Child-Pugh C Liver Cirrhosis
- Tumor volume > 50% combined with an albumin < 3 g/dL
- Complete occlusion of main portal vein causing portal hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase II Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres As First-Line Treatment For Cholangiocarcinoma
The purpose of this study is to see if Therasphere will be a better way to treat cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this treatment will have on the patient and their cancer.
Read the detailed description
The goal of treatment with TheraSphere is to allow a large dose of radiation to be delivered directly to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue when compared with currently available treatments.
The standard treatment for cholangiocarcinoma is surgery (if possible), external beam radiation therapy and/or chemotherapy. External beam radiation therapy to the liver may reduce symptoms, but only 20% of patients experience significant tumor shrinkage. Chemotherapy has response rates ranging from 6-19%. More recently, a new approach has been developed, called TheraSphere. Based on the results of earlier studies with TheraSphere, the study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for this disease.
TheraSphere has restricted approval from the United States Food and Drug Administration (FDA) for the treatment of hepatocellular liver cancer; but it has not yet been approved for the treatment of cholangiocarcinoma. TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
- Conditions
- Cholangiocarcinoma
- Being tested
- TheraSphere® Yttrium-90 (Y-90) Microspheres
- Keywords
- Liver, Bile Duct
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphere® Yttrium-90 (Y-90) MicrospheresDevice
Also called 90y, Intrahepatic Arterial Injection, Radiotherapy, Radioactive Microspheres
Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
| Study group | Role | What they receive |
|---|---|---|
| Arterial Injection of 90-Y Microspheres | Experimental | Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma Receives: Device: TheraSphere® Yttrium-90 (Y-90) Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression Free Survival (PFS)
PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: End of post treatment follow-up period of 20 months
Secondary outcomes (2)
Median Overall Survival (OS)
OS is defined as the duration of time from enrollment to time of death from any cause.
Measured: Up to 36 months
Overall Response Rate (ORR)
Tumor Response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all target and non-target lesions; no new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions.
Measured: End of post treatment follow-up period of up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2015
- Study completionAug 2015
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 CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- BTG International Inc.
- Responsible party
- Sponsor
- Investigators
- Sarah Hoffe, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253148
- Sponsor's protocol ID
- MCC-16236
- Other IDs
- NCI-2011-00794
- Status last verified
- Feb 2017
- First submitted
- 1 Dec 2010
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres As First-Line Treatment For Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT01253148
- Acronym / sponsor ID
- MCC-16236
- Conditions
- Cholangiocarcinoma
- Keywords
- Liver, Bile Duct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- BTG International Inc.
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 19 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if Therasphere will be a better way to treat cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this treatment will have on the patient and their cancer.
Detailed description
The goal of treatment with TheraSphere is to allow a large dose of radiation to be delivered directly to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue when compared with currently available treatments.
The standard treatment for cholangiocarcinoma is surgery (if possible), external beam radiation therapy and/or chemotherapy. External beam radiation therapy to the liver may reduce symptoms, but only 20% of patients experience significant tumor shrinkage. Chemotherapy has response rates ranging from 6-19%. More recently, a new approach has been developed, called TheraSphere. Based on the results of earlier studies with TheraSphere, the study doctors at Moffitt feel this is a reasonable alternative to the standard treatment for this disease.
TheraSphere has restricted approval from the United States Food and Drug Administration (FDA) for the treatment of hepatocellular liver cancer; but it has not yet been approved for the treatment of cholangiocarcinoma. TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arterial Injection of 90-Y Microspheres | Experimental | Device: TheraSphere® Yttrium-90 (Y-90) MicrospheresIntrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have newly diagnosed or recurrent (post surgery) histologically or cytologically proven cholangiocarcinoma.
- Patients can have solitary, multifocal unilobar, or bilobar disease without evidence of extrahepatic involvement. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI).
- Age >18 years
- Life expectancy of greater than 3 months based on physician judgment
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 (Karnofsky 50%)
Key exclusion criteria (11 listed)
- Patients receiving any other investigational agents
- Patients with extrahepatic disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because TheraSpheres are radioactive and radiation is a known agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSpheres, breastfeeding should be discontinued if the mother is treated with TheraSpheres.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. In addition, antiretrovirals are known radiation sensitizers and could dramatically increase the risk of fulminant hepatic failure. Therefore, HIV-positive patients are excluded from the study because of possible lethal side effects.
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® Yttrium-90 (Y-90) MicrospheresAlso: 90y, Intrahepatic Arterial Injection, Radiotherapy, Radioactive MicrospheresY-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver. | Device | Arterial Injection of 90-Y Microspheres |
Primary outcome
Median Progression Free Survival (PFS)
Time frame: End of post treatment follow-up period of 20 months
PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
2 secondary outcomes
Median Overall Survival (OS)
Time frame: Up to 36 months
Overall Response Rate (ORR)
Time frame: End of post treatment follow-up period of up to 20 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarah Hoffe, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSphere® Yttrium-90 (Y-90) Microspheres in people with Cholangiocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 15 inclusion and 11 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 22 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2016). 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?
Median Progression Free Survival (PFS) (time frame: End of post treatment follow-up period of 20 months). 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 22 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.