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| Name | Class |
|---|---|
| Columbia University | OTHER |
The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.
Biocompatibles LC Bead (also known as DC Bead in Asia & Europe) microspheres are preformed soft, deformable microspheres that may be loaded with doxorubicin and used to occlude blood flow to a cancerous tumour. LC Bead microspheres consist of a macromere derived from PVA. The fully polymerized microsphere is approximately 90% water and is compressible to approximately 30% by diameter. The microspheres can be delivered through conventional catheters (4-5Fr) or micro-catheters in the 2-3Fr range. These microspheres, like all agents used for arterial embolization, are mixed with radiographic contrast prior to administration in order to allow for fluoroscopic control of the embolization procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bead Arm | Active Comparator | Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident. |
|
| Bead + Dox Arm | Active Comparator | Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bead Block microspheres | Device | Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to Treatment by RECIST Criteria | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | 2 to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Evaluated for Toxicity | Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 3.0. | 1 year |
| Progression Free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen T Brown, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26834067 | Derived | Brown KT, Do RK, Gonen M, Covey AM, Getrajdman GI, Sofocleous CT, Jarnagin WR, D'Angelica MI, Allen PJ, Erinjeri JP, Brody LA, O'Neill GP, Johnson KN, Garcia AR, Beattie C, Zhao B, Solomon SB, Schwartz LH, DeMatteo R, Abou-Alfa GK. Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone. J Clin Oncol. 2016 Jun 10;34(17):2046-53. doi: 10.1200/JCO.2015.64.0821. Epub 2016 Feb 1. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bead Arm | Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident. Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis |
| FG001 | Bead + Dox Arm | Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bead Arm | Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident. Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Response to Treatment by RECIST Criteria | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Count of Participants | Participants | 2 to 3 weeks |
|
1 year
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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 | Bead Arm | Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident. Bead Block microspheres: Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Covey, MD | Memorial Sloan Kettering Cancer Center | 212-639-6746 | coveya@MSKCC.ORG |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2019 | Jul 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Bead + Dox Arm | Other | Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. |
|
| 1 year |
| Overall Survival | 1 year |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Bead + Dox Arm |
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. |
|
|
| Secondary | Number of Participants Evaluated for Toxicity | Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 3.0. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Progression Free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | Posted | Median | Standard Deviation | months | 1 year |
|
|
|
| Secondary | Overall Survival | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 48 |
| 51 |
| 48 |
| 51 |
| 33 |
| 51 |
| EG001 | Bead + Dox Arm | Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. Bead + Dox Arm: Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident. | 47 | 50 | 47 | 50 | 28 | 50 |
| Liver abscess | Hepatobiliary disorders | Systematic Assessment |
|
| Liver failure (transient) | Hepatobiliary disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Puncture Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Pulmonary embolus | Vascular disorders | Systematic Assessment |
|
| Death not assoc w CTCAE term- Death | General disorders | Systematic Assessment |
|
| Death not assoc w CTCAE term- Sudden death | General disorders | Systematic Assessment |
|
| Death not assoc w CTCAE term-Disease prog NOS | General disorders | Systematic Assessment |
|
| Death due to disease progression | General disorders | Systematic Assessment |
|
| Alkaline Phosphatase | Investigations | Systematic Assessment |
|
| Allerg react/hypersens (incl drug fever) | Immune system disorders | Systematic Assessment |
|
| ALT, SGPT | Investigations | Systematic Assessment |
|
| Amylase | Investigations | Systematic Assessment |
|
| Ascites (non-malignant) | Gastrointestinal disorders | Systematic Assessment |
|
| AST, SGOT | Investigations | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Investigations | Systematic Assessment |
|
| Blood/Bone Marrow, other | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| CNS cerebrovascular ischemia | Nervous system disorders | Systematic Assessment |
|
| Creatinine | Investigations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Distension/bloating, abdominal | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | Systematic Assessment |
|
| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
|
| Gastritis (incl bile reflux gastritis) | Gastrointestinal disorders | Systematic Assessment |
|
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hemorrhage, Lower GI NOS | Gastrointestinal disorders | Systematic Assessment |
|
| Hemorrhage, Rectum | Gastrointestinal disorders | Systematic Assessment |
|
| Hemorrhage, Varices (esophageal) | Gastrointestinal disorders | Systematic Assessment |
|
| Hemorrhage/Bleeding, other | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hepatobiliary/Pancrease, other | Hepatobiliary disorders | Systematic Assessment |
|
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ileus, GI (func obstruction of bowel) | Gastrointestinal disorders | Systematic Assessment |
|
| Inf norm ANC/gr1/2 neut- Pneumonia(lung) | Investigations | Systematic Assessment |
|
| Inf unknown ANC-Cellulitis(skin) | Infections and infestations | Systematic Assessment |
|
| Infection w/ Gr 3/4 neut, Urinary tract NOS | Infections and infestations | Systematic Assessment |
|
| INR | Investigations | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Leak, GI- Biliary tree | Gastrointestinal disorders | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lipase | Investigations | Systematic Assessment |
|
| Liver dysfunction/failure | Hepatobiliary disorders | Systematic Assessment |
|
| Lymphopenia | Investigations | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |