NCT00152087

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

September 9, 2005

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

September 7, 2005

Conditions

Liver Cancer

Keywords

Liver cancerBrachytherapy

Outcome Measures

Primary Outcomes (5)

  • Efficacy

  • - Response to treatment

  • - Survival time from treatment

  • Safety:

  • - Adverse experience

Interventions

BrachytherapyDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • month post chemotherapy
  • Serum Bilirubin \< 2.0
  • Acceptable white blood count

You may not qualify if:

  • Co-morbid disease that would place patient at undue risk.
  • Pre-existing diarrhea/illness
  • Pregnant
  • Fail preliminary MAA testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital

Tampa, Florida, 33607, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Alison R. Calkins, MD

    St. Joseph's Hospital, Tampa, FL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Pritchard, RN, OCN

CONTACT

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

Ronda Buffington, RN, OCN

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

October 1, 2002

Study Completion

June 1, 2005

Last Updated

September 9, 2005

Record last verified: 2005-09

Locations

US(1)