Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Inclusion Criteria
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
- Ineligible for surgical resection
- Life expectancy >= 3 months
- ...
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
- Ineligible for surgical resection
- Life expectancy >= 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Diagnosis of intrahepatic malignancy including but not limited to HCC; 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-fetoprotein (AFP) and clinical findings
- > 4 weeks since prior radiation, surgery or chemotherapy
Exclusion Criteria
- Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Active uncontrolled infection
- ...
- Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Active uncontrolled infection
- Severe peripheral vascular disease that would preclude catheterization
- Pregnancy
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
- Evidence of pulmonary insufficiency
- Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
- Bleeding diathesis, not correctable by usual forms of therapy
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
- Significant underlying medical or psychiatric illness
- Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Summary
- Conditions
- Adult Primary Hepatocellular Carcinoma
- Advanced Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 8 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates. II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment. OUTLINE: Pat...
PRIMARY OBJECTIVES: I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates. II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment. OUTLINE: Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician. After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.
Inclusion Criteria
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
- Ineligible for surgical resection
- Life expectancy >= 3 months
- ...
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
- Ineligible for surgical resection
- Life expectancy >= 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Diagnosis of intrahepatic malignancy including but not limited to HCC; 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-fetoprotein (AFP) and clinical findings
- > 4 weeks since prior radiation, surgery or chemotherapy
Exclusion Criteria
- Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Active uncontrolled infection
- ...
- Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Active uncontrolled infection
- Severe peripheral vascular disease that would preclude catheterization
- Pregnancy
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
- Evidence of pulmonary insufficiency
- Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
- Bleeding diathesis, not correctable by usual forms of therapy
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
- Significant underlying medical or psychiatric illness
- Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Tracking Information
- NCT #
- NCT02072356
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rikabi Ali, M.D. Ohio State University Comprehensive Cancer Center
- Rikabi Ali, M.D. Ohio State University Comprehensive Cancer Center