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

St. Joseph's Hospital, Florida

Status and phase: Unknown; Phase 2

Conditions: Liver Cancer

Treatments: Device: Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00152087

Alison Calkins, MD

SJCI015

Matthew Berlet, MD

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)