Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
100

Inclusion Criteria

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
Ineligible for surgical resection
...
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
Ineligible for surgical resection
Life expectancy >= 3 months
> 4 weeks since prior radiation, surgery or chemotherapy
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

Significant underlying medical or psychiatric illness
Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Significant extrahepatic disease representing an imminent life-threatening outcome
...
Significant underlying medical or psychiatric illness
Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Significant extrahepatic disease representing an imminent life-threatening outcome
Bleeding diathesis, not correctable by usual forms of therapy
Pregnancy
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
History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
Active uncontrolled infection
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
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
Severe peripheral vascular disease that would preclude catheterization

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

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
Ineligible for surgical resection
...
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
Ineligible for surgical resection
Life expectancy >= 3 months
> 4 weeks since prior radiation, surgery or chemotherapy
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

Significant underlying medical or psychiatric illness
Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Significant extrahepatic disease representing an imminent life-threatening outcome
...
Significant underlying medical or psychiatric illness
Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
Significant extrahepatic disease representing an imminent life-threatening outcome
Bleeding diathesis, not correctable by usual forms of therapy
Pregnancy
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
History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
Active uncontrolled infection
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
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
Severe peripheral vascular disease that would preclude catheterization

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
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