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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.
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by St. Joseph's Hospital, Florida.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
St. Joseph's Hospital, Florida
Information provided by:
St. Joseph's Hospital, Florida
ClinicalTrials.gov Identifier:
NCT00152087
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Liver Cancer | Device: Brachytherapy | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol. |
Resource links provided by NLM:
Further study details as provided by St. Joseph's Hospital, Florida:
Primary Outcome Measures:
- Efficacy
- - Response to treatment
- - Survival time from treatment
- Safety:
- - Adverse experience
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | June 2005 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152087
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152087
Contacts
| Contact: Mary Pritchard, RN, OCN | 813-870-4257 | Mary.Pritchard@baycare.org | |
| Contact: Ronda Buffington, RN, OCN | 813-870-4123 | Ronda.buffington@baycare.org |
Locations
| United States, Florida | |
| St. Joseph's Hospital | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Ronda Buffington, RN,OCN 813-870-4123 Ronda.Buffington@baycare.org | |
| Contact: Mary Pritchard, RN, OCN 813-870-4257 Mary.Pritchard@baycare.org | |
Sponsors and Collaborators
St. Joseph's Hospital, Florida
Investigators
| Principal Investigator: | Alison R. Calkins, MD | St. Joseph's Hospital, Tampa, FL |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00152087 History of Changes |
| Other Study ID Numbers: |
SJCI015 Alison Calkins, MD Matthew Berlet, MD |
| Study First Received: | September 7, 2005 |
| Last Updated: | September 7, 2005 |
Keywords provided by St. Joseph's Hospital, Florida:
|
Liver cancer Brachytherapy |
Additional relevant MeSH terms:
|
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 28, 2017