N/A
N=11
HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00605150 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Progression — 11 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- TheraSphere-Yttrium 90 microsphere (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression |
11 | — |
| SECONDARY Number of Participants With Unacceptable Side Effects After Treatment |
— | — |
Summary
MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can have placement of appropriately positioned hepatic arterial catheters. Outcomes of this treatment protocol will be monitored and reported to the Carolinas HealthCare System Institutional Review Board.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of intrahepatic carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha feta protein (AFP) markers (clinical diagnosis).
- The cancer must be unresectable.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
- Age greater than or equal to 18
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria
- Any pre-treatment lab findings within 15 days of treatment demonstrating: absolute granulocyte count less than or equal to 1,500/ul, platelet count less than or equal to 45,000/ul, serum creatinine greater than or equal to 3.0 mg/dl, serum bilirubin greater than or equal to 4.0 mg/dl
- Any of the following contraindications to angiography and selective visceral catheterization: history of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine; bleeding diathesis, not correctable by usual forms of therapy; 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 milliCurie (mCi) or 30 gray (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 microaggregate albumin (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 or pulmonary insufficiency
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness.
- Pregnant women may not participate.
Data sourced from ClinicalTrials.gov (NCT00605150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.