A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®
This study is currently recruiting participants.
Verified October 2012 by St. Joseph Hospital of Orange
Sponsor:
St. Joseph Hospital of Orange
Information provided by (Responsible Party):
St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier:
NCT00877136
First received: April 3, 2009
Last updated: October 18, 2012
Last verified: October 2012
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Purpose
This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives:
- Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
- Evaluate patient experience and toxicities associated with TheraSphere® treatment.
- Measure tumor response rates
| Condition | Intervention |
|---|---|
|
Liver Tumors Hepatocellular Carcinoma Hepatoma Neoplasms |
Device: TheraSphere® |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere® |
Resource links provided by NLM:
Further study details as provided by St. Joseph Hospital of Orange:
Primary Outcome Measures:
- Evaluate patient quality of life and toxicities associated with TheraSphere® treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Tumor response to treatment with TheraSphere® [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Device: TheraSphere®
TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.
The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients from St. Joseph Hospital of Orange, community members in the St. Joseph Hospital service area and surrounding areas
Criteria
Inclusion Criteria:
- Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass with known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis)
- Surgical evaluation must conclude the patient is not a candidate for resection or ablation.
- ECOG Performance Status Score 0 - 2.
- Age 18 years or older.
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- Absolute granulocyte count less than or equal to 1,500/ul
- Uncorrected Platelet count less than or equal to 75,000/ul
- Serum creatinine greater than or equal to 3.0 mg/dl
- Serum bilirubin greater than or equal to 2.0 mg/dl
- Any of the following contraindications to angiography and selective visceral catheterization, 1.)History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude catheterization.
- Portal hypertension with portal venous shunt away from the liver.
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere® administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
- Significant extrahepatic disease representing an imminent life-threatening outcome.
- Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy).
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness.
- Pregnant women may not participate.
- Children may not participate due to lack of clinical experience.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877136
Contacts
| Contact: Jessica Silvester | 714-734-6220 | |
| Contact: Maria Gonzalez | 714-734-6220 |
Locations
| United States, California | |
| The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Jessica Silvester 714-734-6220 | |
| Contact: Gitana Davila 714-734-6220 ext 41477 | |
| Principal Investigator: Lawrence Wagman, M.D., F.A.C.S. | |
| Sub-Investigator: Robert Ash, MD | |
| Sub-Investigator: Afshin Forouzannia, MD | |
| Sub-Investigator: Judith Harrison-Monge, MD | |
| Sub-Investigator: Timothy Byun, MD | |
| Sub-Investigator: Hisham El-Bayar, MD | |
| Sub-Investigator: Kurt Openshaw, MD | |
| Sub-Investigator: Mahmood Razavi, MD | |
Sponsors and Collaborators
St. Joseph Hospital of Orange
Investigators
| Principal Investigator: | Lawrence Wagman, M.D., F.A.C.S. | St. Joseph Hospital of Orange |
More Information
No publications provided
| Responsible Party: | St. Joseph Hospital of Orange |
| ClinicalTrials.gov Identifier: | NCT00877136 History of Changes |
| Other Study ID Numbers: | 08-029 TheraSphere® |
| Study First Received: | April 3, 2009 |
| Last Updated: | October 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Joseph Hospital of Orange:
|
Liver tumors Liver cancer Adult primary hepatocellular carcinoma |
HCC Hepatoma Neoplasms |
Additional relevant MeSH terms:
|
Carcinoma, Hepatocellular Neoplasms Carcinoma Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma |
ClinicalTrials.gov processed this record on June 17, 2013