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Liver Extracts

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

120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe

Yttrium 90 glass microspheres

Al Benson III, MD

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.

TheraSphere for the Treatment of Liver Metastases

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

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.

Duration of survival from date of first TheraSphere treatment to date of death or censored to last known date alive.

BTG International Inc.

Boston Scientific Corporation

total population receiving at least one TheraSphere treatment

TheraSphere

colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy

Colorectal Cancer

neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy

Neuroendocrine Cancer

patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy

Non-Colorectal/Non-neuroendocrine

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Subjects treated with TheraSphere were enrolled and assigned to groups based on their primary cancer type. The total population and each subgroup population was analyzed for safety, progression and survival endpoints. In the neuroendocrine group, a median overall survival was not achieved so a post-hoc analysis of 2 year survival was performed.

Director of Clinical Operations

Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0

Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0

Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0

All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups

All Patients

Patients receiving at least one TheraSphere treatment with images evaluable by RECIST

Hepatic Progression-free Survival According to Response Evaluation Criterian in Solid Tumors (RECIST)

Patients with metastatic liver disease arising from primary cancers other than colorectal or neuroendocrine cancer who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0

Non Colorectal/Non-Neuroendocrine

In the neuroendocrine group, a median overall survival was not achieved so a post-hoc analysis of 2 year survival was performed in Outcome Measure 3.

Overall Survival

The percentage of patients in the neuroendocrine group alive at 2 years

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TheraSphere for the Treatment of Liver Metastases	NCT00511862	Colorectal Canc... Carcinoma, Neur... Neoplasm Metast...	Yttrium 90 glas...	18 Years -	Boston Scientific Corporation
TheraSphere for the Treatment of Liver Metastases	NCT00511862	Colorectal Canc... Carcinoma, Neur... Neoplasm Metast...	Yttrium 90 glas...	18 Years -	Boston Scientific Corporation

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