Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Principal Investigator

Alison R. Calkins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Joseph's Hospital, Tampa, FL

Authority:

United States: Food and Drug Administration

Study ID:

SJCI015

NCT ID:

NCT00152087

Start Date:

October 2002

Completion Date:

June 2005

Related Keywords:

  • Liver Cancer
  • Liver cancer
  • Brachytherapy
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

St. Joseph's HospitalTampa, Florida  33607