Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Tampa, Florida 33607


Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: - 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 - Greater than 4 weeks since prior radiation therapy or surgery - 1 month post chemotherapy - Serum Bilirubin < 2.0 - Acceptable white blood count Exclusion Criteria: - Co-morbid disease that would place patient at undue risk. - Pre-existing diarrhea/illness - Pregnant - Fail preliminary MAA testing


Study is Available At:


Original ID:

SJCI015


NCT ID:

NCT00152087


Secondary ID:

Alison Calkins, MD


Study Acronym:


Brief Title:

A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.


Official Title:

Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

St. Joseph's Hospital, Florida


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:


Overall Contact Information

Official Name:Alison R. Calkins, MD
Principal Investigator
St. Joseph's Hospital, Tampa, FL
Primary Contact:Mary Pritchard, RN, OCN
813-870-4257
Mary.Pritchard@baycare.org
Backup Contact:Ronda Buffington, RN, OCN
813-870-4123
Ronda.buffington@baycare.org

Study Dates

Start Date:October 2002
Completion Date:June 2005
Verification Date:September 2005
Last Changed Date:September 7, 2005
First Received Date:September 7, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:- Adverse experience
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety:
Safety Issues:False
Outcome Type:Primary Outcome
Measure:- Survival time from treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:- Response to treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Efficacy
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Brachytherapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Joseph's Hospital, Florida

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.