Recruiting
Phase 2

Internal Radiation Therapy

Sponsor:

St. Joseph's Hospital, Florida

Code:

NCT00152087

Conditions

Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brachytherapy

Study Details

Brief 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.

Conditions

Liver Cancer

Study ID

NCT00152087

Start date

Oct, 2002

Status verified date

Sep, 2005

Completion date

Jun, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Brachytherapy

Primary outcome measure

  • Efficacy [ Time Frame: undefined ]
  • - Response to treatment [ Time Frame: undefined ]
  • - Survival time from treatment [ Time Frame: undefined ]
  • Safety: [ Time Frame: undefined ]
  • - Adverse experience [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Mary Pritchard, RN, OCN

813-870-4257Mary.Pritchard@baycare.org

Ronda Buffington, RN, OCN

813-870-4123Ronda.buffington@baycare.org

Locations

St. Joseph's Hospital

Recruiting

Tampa, Florida, United States, 33607

Contacts

Ronda Buffington, RN,OCN

813-870-4123Ronda.Buffington@baycare.org

Mary Pritchard, RN, OCN

813-870-4257Mary.Pritchard@baycare.org

More Information

Sponsor

St. Joseph's Hospital, Florida

Last update posted

Sep 9, 2005

Last verified

Sep, 2005

Keywords

  • Liver cancer
  • Brachytherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital, Florida on 2005-09-09.