A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®

NCT00877136 | Completed

• 1 other identifier: 08-029 TheraSphere®
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
2. 2.Evaluate patient experience and toxicities associated with TheraSphere® treatment.
3. 3.Measure tumor response rates

Conditions

Liver Tumors; Hepatocellular Carcinoma; Hepatoma; Neoplasms

Keywords

Liver tumors; Liver cancer; Adult primary hepatocellular carcinoma; HCC; Hepatoma; Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of patients given access to treatment with TheraSphere.

  The number of eligible patients provided with supervised access to treatment with TheraSphere with primary cancer to the liver who are not surgical resection candidates.

  24 months

• Evaluate patient experience with Therasphere.

  Evaluation of patient experience and toxicities associated with Therasphere via patient follow-ups with clinician notes.

  24 months

Secondary Outcomes (1)

• Tumor response to treatment with TheraSphere®

  24 Months

Interventions

TheraSphere® DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph Hospital of Orange: lead

Study Sites (1)

The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Lawrence Wagman, M.D., F.A.C.S.

  St. Joseph Hospital of Orange

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 7, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2021
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

US (1)