TheraSphere for the Treatment of Liver Metastases

Study Overview
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Brief Summary
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This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.

Official Title
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TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer

Conditions
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Colorectal Cancer, Carcinoma, Neuroendocrine, Neoplasm Metastasis

Intervention / Treatment
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* Device: Yttrium 90 glass microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies unresectable liver metastases target tumors measurable using standard imaging techniques tumor replacement < or = 50% of total liver volume (visual estimation by investigator) Hypervascular tumors (visual estimation by investigator) Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer patient informed consent Exclusion Criteria: At risk of hepatic or renal failure within 21 days of treatment (serum creatinine > 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin < 2.0 mg/dL or any history of hepatic encephalopathy) contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease cirrhosis or portal hypertension prior external beam radiation treatment to the liver prior TheraSphere treatment to the liver any intervention for, or compromise of the Ampulla of Vater clinically evident ascites (trace ascites on imaging is acceptable) any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment significant life-threatening extrahepatic disease in judgment of physician concurrent enrollment in another study alternative available therapies in judgement of physician evidence on technetium-99m macroaggregated albumin scan that shows lung shunting > 30 Gy cumulative limit evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques positive serum pregnancy test in women of childbearing potential co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TheraSphere<br>Single arm, TheraSphere Yttrium 90 glass microspheres at 120 Gy +/- 10%; stratified by type of disease (colorectal cancer, neuroendocrine cancer, non-colorectal/non-neuroendocrine cancer | Device: Yttrium 90 glass microspheres<br>* 120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe<br>* Other names: TheraSphere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST) | Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression. | From the date of first treatment until date of first documented progression; median patient follow-up 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive. | Time from first TheraSphere treatment to death; median follow up 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TheraSphere, radioactive microspheres, Yttrium-90, Yttrium glass microspheres