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
- Ineligible for surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Life expectancy >= 3 months
- ...
- Ineligible for surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Life expectancy >= 3 months
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
- > 4 weeks since prior radiation, surgery or chemotherapy
- 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
Exclusion Criteria
- Evidence of pulmonary insufficiency
- Severe peripheral vascular disease that would preclude catheterization
- 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
- ...
- Evidence of pulmonary insufficiency
- Severe peripheral vascular disease that would preclude catheterization
- 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
- Active uncontrolled infection
- Pregnancy
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Significant underlying medical or psychiatric illness
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
- Bleeding diathesis, not correctable by usual forms of therapy
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
- Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
- 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
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
- Ineligible for surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Life expectancy >= 3 months
- ...
- Ineligible for surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Life expectancy >= 3 months
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
- > 4 weeks since prior radiation, surgery or chemotherapy
- 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
Exclusion Criteria
- Evidence of pulmonary insufficiency
- Severe peripheral vascular disease that would preclude catheterization
- 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
- ...
- Evidence of pulmonary insufficiency
- Severe peripheral vascular disease that would preclude catheterization
- 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
- Active uncontrolled infection
- Pregnancy
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Significant underlying medical or psychiatric illness
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
- Bleeding diathesis, not correctable by usual forms of therapy
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
- Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
- 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
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