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

NCT ID: NCT00152087

Condition: Liver Cancer

Conditions: Official terms:
Liver Neoplasms

Conditions: Keywords:
Liver cancer
Brachytherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Brachytherapy

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. 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

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: St. Joseph's Hospital

Address:
City: Tampa
Zip: 33607
Country: United States

Status: Recruiting

Contact:
Last name: Ronda Buffington, RN,OCN

Phone: 813-870-4123
Email: Ronda.Buffington@baycare.org

Contact backup:
Last name: Mary Pritchard, RN, OCN

Phone: 813-870-4257
Email: Mary.Pritchard@baycare.org

Start date: October 2002

Completion date: June 2005

Lead sponsor:
Agency: St. Joseph's Hospital, Florida
Agency class: Other

Source: St. Joseph's Hospital, Florida

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00152087
http://www.sjbhealth.org

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