TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | October 2007 |
| End Date: | December 2021 |
| Contact: | Colette Shaw, MD |
| Phone: | 215-955-8619 |
A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma
TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has
been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere),
it can be injected into the liver through a blood vessel. This allows a large local dose of
radiation to be delivered to the tumor with less risk of toxic effects from radiation to
other parts of the body or to healthy liver tissue.
been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere),
it can be injected into the liver through a blood vessel. This allows a large local dose of
radiation to be delivered to the tumor with less risk of toxic effects from radiation to
other parts of the body or to healthy liver tissue.
Surgical resection of the affected portion of the liver offers the best chance for
disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma patients
present with disease that is not amenable to resection (multifocal disease) or have other
medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis
or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical candidates.
The objective of treatment with TheraSphere is to selectively administer a potentially lethal
dose of radioactive material to neoplastic tissue in the liver of patients with HCC. Regional
therapies for HCC may have several advantages over systemically administered treatments.
Irradiating a cancer prior to treatment with regional chemotherapy may be more effective than
either therapeutic modality alone. TheraSphere may also be of value as a 'bridging' treatment
for HCC patients awaiting a donor organ for liver transplantation.
disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma patients
present with disease that is not amenable to resection (multifocal disease) or have other
medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis
or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical candidates.
The objective of treatment with TheraSphere is to selectively administer a potentially lethal
dose of radioactive material to neoplastic tissue in the liver of patients with HCC. Regional
therapies for HCC may have several advantages over systemically administered treatments.
Irradiating a cancer prior to treatment with regional chemotherapy may be more effective than
either therapeutic modality alone. TheraSphere may also be of value as a 'bridging' treatment
for HCC patients awaiting a donor organ for liver transplantation.
Inclusion Criteria:
- Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma
of the liver
- Patients who are able to give informed consent, will be eligible.
- Patients must have an ECOG Performance Status score of < or = 2
- Must have a life expectancy of > 3 months
- Non-pregnant with an acceptable contraception in premenopausal women
- Patients must be > 4 weeks since prior radiation or prior surgery and at least 1 month
post chemotherapy
Exclusion Criteria:
- Contraindications to angiography and selective visceral catheterization
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) per
treatment of radiation to the lungs
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after
application of established angiographic techniques to stop or mitigate such flow (ex.
placing catheter distal to gastric vessels)
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Severe liver dysfunction or pulmonary insufficiency
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Pregnancy
- Patients will be excluded if they have pre-existing diarrhea/illness, or if they have
a co-morbid disease or condition that would preclude safe delivery of TheraSphere
treatment and place the patient at undue risk.
We found this trial at
1
site
1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-8619
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
Click here to add this to my saved trials
