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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

Last Updated: 2005-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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

Conditions

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Liver Cancer

Keywords

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Liver cancer Brachytherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Brachytherapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Hospital, Florida

OTHER

Sponsor Role lead

Principal Investigators

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Alison R. Calkins, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Hospital, Tampa, FL

Locations

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St. Joseph's Hospital

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mary Pritchard, RN, OCN

Role: CONTACT

Phone: 813-870-4257

Email: [email protected]

Ronda Buffington, RN, OCN

Role: CONTACT

Phone: 813-870-4123

Email: [email protected]

Facility Contacts

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Ronda Buffington, RN,OCN

Role: primary

Mary Pritchard, RN, OCN

Role: backup

Other Identifiers

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Alison Calkins, MD

Identifier Type: -

Identifier Source: secondary_id

Matthew Berlet, MD

Identifier Type: -

Identifier Source: secondary_id

SJCI015

Identifier Type: -

Identifier Source: org_study_id