Liver CancerPhase 2NCT00152087
A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.
A Phase 2 study testing Brachytherapy in people with Liver Cancer, run by St. Joseph's Hospital, Florida at 1 site in United States.
Trial summary
Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Brachytherapy
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jun 2005
- Phase
- Phase 2
- 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
Who may be able to join
- Over 18 years of age of any sex, race
- Histological proof of HCC
- Able to give Informed Consent
- ECOG performance equal or less than 2
- Life expectancy equal to or greater than 3 months
- Non- pregnant with acceptable contraception in premenopausal women
Show all 10Show fewer
- Greater than 4 weeks since prior radiation therapy or surgery
- 1 month post chemotherapy
- Serum Bilirubin < 2.0
- Acceptable white blood count
Who cannot join
- Co-morbid disease that would place patient at undue risk.
- Pre-existing diarrhea/illness
- Pregnant
- Fail preliminary MAA testing
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Joseph's Hospital
Tampa, Florida, 33607
Ronda Buffington, RN,OCN, 813-870-4123, Ronda.Buffington@baycare.org
Mary Pritchard, RN, OCN, 813-870-4257, Mary.Pritchard@baycare.org
About this study
Official title: Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.
Read the detailed description
Protocol Objectives include:
- Determine the proportion of patients with HCC in whom the treatment plan can be completed
- Evaluate the response to therapy
- Evaluate toxicities and adverse experiences associated with TheraSphere treatment
- Evaluate survival time
- Conditions
- Liver Cancer
- Being tested
- Brachytherapy
- Keywords
- Liver cancer, Brachytherapy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
- Response to treatment
- Survival time from treatment
Safety:
- Adverse experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startOct 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital, Florida
- Sponsor type
- University, hospital or other
- Investigators
- Alison R. Calkins, MD, Principal investigator, St. Joseph's Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152087
- Sponsor's protocol ID
- SJCI015
- Other IDs
- Alison Calkins, MD, Matthew Berlet, MD
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 9 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
- ClinicalTrials.gov ID
- NCT00152087
- Acronym / sponsor ID
- SJCI015
- Conditions
- Liver Cancer
- Keywords
- Liver cancer, Brachytherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants
- Lead sponsor
- St. Joseph's Hospital, FloridaUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Jun 2005
- First posted
- 9 Sep 2005 (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.
Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.
Detailed description
Protocol Objectives include:
- Determine the proportion of patients with HCC in whom the treatment plan can be completed
- Evaluate the response to therapy
- Evaluate toxicities and adverse experiences associated with TheraSphere treatment
- Evaluate survival time
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Over 18 years of age of any sex, race
- Histological proof of HCC
- Able to give Informed Consent
- ECOG performance equal or less than 2
- Life expectancy equal to or greater than 3 months
Key exclusion criteria (4 listed)
- Co-morbid disease that would place patient at undue risk.
- Pre-existing diarrhea/illness
- Pregnant
- Fail preliminary MAA testing
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 |
|---|---|---|
| Brachytherapy | Device | – |
Primary outcome
Efficacy
- Response to treatment
- Survival time from treatment
Safety:
- Adverse experience
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2005.
- St Joseph's Hospital web siteLink provided by the sponsor.
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Alison R. Calkins, MD principal investigator
St. Joseph's Hospital, Tampa, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brachytherapy in people with Liver Cancer, run by St. Joseph's Hospital, Florida 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 10 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Sep 2005. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary Pritchard, RN, OCN (813-870-4257, Mary.Pritchard@baycare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy. The study lists 5 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 9 Sep 2005.