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This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yttrium-90 liver radioembolization | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere) | Device | Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Response | Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition.
Previous radiation therapy to the lungs and/or to the upper abdomen
Pregnancy
Symptomatic lung disease.
Significant extrahepatic disease representing an imminent life-threatening outcome.
Active uncontrolled infection
Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
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Between May 2010 and October 2013, 42 adult patients with liver-dominant metastaticd colorectal or neuroendocrine cancer to the liver, or intrahepatic cholangiocarcinoma were enrolled in a prospective single-institution pilot study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Yttrium-90 Radioembolization | Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 6 months after treatment |
| COMPLETED |
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| NOT COMPLETED |
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per protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Yttrium-90 Radioembolization | Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration. | Posted | Number | participants | 6 months |
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| Secondary | Radiographic Response | Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions. | Response data are presented by primary disease sites: Colorectal (mCRC), Neuroendocrine (NET), and all other tumors. One patient with mCRC did not have follow-up cross-sectional imaging. Therefore, radiographic response data was available for 20 of 21 patients with mCRC. | Posted | Number | participants | 6 months after treatment |
|
6 months after treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yttrium-90 Liver Radioembolization | Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere) | 3 | 42 | 42 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization for carcinoid crisis | Blood and lymphatic system disorders | Non-systematic Assessment | Only patients with neuroendocrine tumors were at risk for carcinoid crisis. Therefore denominator for this adverse event is 11, not 42. |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | grade 3 |
| |
| gastric ulcer | Gastrointestinal disorders | Systematic Assessment | grade 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| PT/INR | Blood and lymphatic system disorders | Systematic Assessment | Coagulation |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Rigors | General disorders | Non-systematic Assessment |
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| Sweating | General disorders | Systematic Assessment |
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| Flushing | General disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Ulcer | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Edema | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Albuminemia | Metabolism and nutrition disorders | Systematic Assessment |
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| ALT | Metabolism and nutrition disorders | Systematic Assessment |
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| AST | Metabolism and nutrition disorders | Systematic Assessment |
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| Bilirubin | Metabolism and nutrition disorders | Systematic Assessment |
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| Creatinine | Metabolism and nutrition disorders | Systematic Assessment |
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| Muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Abdominal pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicholas Fidelman, MD | University of California San Francisco | 1-415-353-1300 | Nicholas.Fidelman@ucsf.edu |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D018281 | Cholangiocarcinoma |
| D008545 | Melanoma |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001941 | Breast Diseases |
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Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
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