{
    "info": {
        "nct_id": "NCT00766220",
        "official_title": "Phase II Randomized Study of SIR-Spheres, Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Metastases to the Liver",
        "inclusion_criteria": "1. Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Histology from the hepatic metastasis is not mandatory if the morphological appearances on cross sectional imaging and tumor markers (CEA) are indicative of a colorectal primary.\n2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in two dimensions (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.\n3. Patients must have radiological evidence of disease progression of disease within 6 months of their most recent dose of chemotherapeutic regimens .\n4. Age greater than or equal to 18 years.\n5. ECOG performance status less than or equal to 2.\n6. Patients must have normal organ and marrow function as defined below within 30 days of receiving the investigational agent: - leukocytes greater than or equal to 3,000/mL - absolute neutrophil count greater than or equal to 1,500/mL - platelets greater than or equal to 100,000/mL - total bilirubin less than or equal to 1.5 times upper limits of normal institutional limits - AST(SGOT) less than or equal to 3 X ULN and ALT(SGPT) less than or equal to 3 X ULN - Creatinine less than or equal to 1.5 times upper limits of normal institutional limits\n7. Patients with a prior history of non-colorectal cancer who have no active disease may be eligible if they are disease free for greater than or equal to 12 months prior to treatment.\n8. The effects of SIR-Spheres, irinotecan or cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radiation as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately.\n9. Ability to understand and the willingness to sign a written informed consent document.\n10. Patients without evidence of local disease recurrence from colorectal cancer are eligible\n11. Patients with extrahepatic disease confined to the lung is permitted if < 4 lesions are depicted on CTand all are < 3 cm in size\n12. Patients with brain mets are eligible for this trial if those patients who have had the area surgically resected or irradiated and have no evidence of active disease as demonstrated by MRI of the brain. Patients must have no evidence of residual neurological dysfunction as per baseline neurological exam. Patients with untreated brain metastases will be considered ineligible.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier will be excluded. Patients who have had hepatic external beam radiotherapy will be excluded.\n2. Patients may not be receiving any other investigational agents.\n3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to SIR-Spheres, irinotecan or cetuximab or other agents used in the study.\n4. Evidence of ascites, biopsy proven cirrhosis or portal hypertension suggested by the presence of characteristic imaging features on cross sectional imaging or esophageal varicosities demonstrated on endoscopy or barium swallow. A diagnostic study to rule out the presence of portal hypertension will not be required unless the findings on cross sectional imaging are suggestive but not confirmatory.\n5. Hepatic arterial anatomy that would prevent catheterization and the administration of SIR-Spheres into the liver.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospital admission or antibiotics,symptomatic congestive heart failure (class III and IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations would exclude patients from this study.\n7. Contraindications to angiography and selective visceral catheterization: History of severe allergy or intolerance to any contrast media, or atropine. Bleeding diathesis, not correctable by usual forms of therapy that would include medical coagulopathy but not limited to the administration of blood products.\n8. Utilization of capecitabine for the 6 weeks preceding SIR-Sphere therapy and indefinitely following SIR-Sphere therapy as per manufacturer's recommendations due to the increased risk of radiation hepatitis.\n9. Patients exhibiting the mutant variety for kras will be excluded for participation in the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in two dimensions (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.",
                "criterions": [
                    {
                        "exact_snippets": "measurable disease, defined as at least one lesion that can be accurately measured in two dimensions",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "one lesion that can be accurately measured in two dimensions (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques",
                        "criterion": "lesion size with conventional techniques",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "one lesion that can be accurately measured in two dimensions (longest diameter to be recorded) ... as greater than or equal to 10 mm with spiral CT scan",
                        "criterion": "lesion size with spiral CT scan",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "measurable disease, defined as at least one lesion that can be accurately measured in two dimensions",
                                "criterion": "measurable disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "one lesion that can be accurately measured in two dimensions (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques",
                                        "criterion": "lesion size with conventional techniques",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 20,
                                                "unit": "mm"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "one lesion that can be accurately measured in two dimensions (longest diameter to be recorded) ... as greater than or equal to 10 mm with spiral CT scan",
                                        "criterion": "lesion size with spiral CT scan",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 10,
                                                "unit": "mm"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patients must have radiological evidence of disease progression of disease within 6 months of their most recent dose of chemotherapeutic regimens .",
                "criterions": [
                    {
                        "exact_snippets": "radiological evidence of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": "radiological"
                        }
                    },
                    {
                        "exact_snippets": "within 6 months of their most recent dose of chemotherapeutic regimens",
                        "criterion": "time since last chemotherapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "radiological evidence of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "evidence",
                            "expected_value": "radiological"
                        }
                    },
                    {
                        "exact_snippets": "within 6 months of their most recent dose of chemotherapeutic regimens",
                        "criterion": "time since last chemotherapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Age greater than or equal to 18 years.",
                "criterions": [
                    {
                        "exact_snippets": "Age greater than or equal to 18 years.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age greater than or equal to 18 years.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. ECOG performance status less than or equal to 2.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status less than or equal to 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status less than or equal to 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Patients must have normal organ and marrow function as defined below within 30 days of receiving the investigational agent: - leukocytes greater than or equal to 3,000/mL - absolute neutrophil count greater than or equal to 1,500/mL - platelets greater than or equal to 100,000/mL - total bilirubin less than or equal to 1.5 times upper limits of normal institutional limits - AST(SGOT) less than or equal to 3 X ULN and ALT(SGPT) less than or equal to 3 X ULN - Creatinine less than or equal to 1.5 times upper limits of normal institutional limits",
                "criterions": [
                    {
                        "exact_snippets": "leukocytes greater than or equal to 3,000/mL",
                        "criterion": "leukocytes",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "absolute neutrophil count greater than or equal to 1,500/mL",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets greater than or equal to 100,000/mL",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "total bilirubin less than or equal to 1.5 times upper limits of normal institutional limits",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limits of normal institutional limits"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST(SGOT) less than or equal to 3 X ULN",
                        "criterion": "AST(SGOT)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT(SGPT) less than or equal to 3 X ULN",
                        "criterion": "ALT(SGPT)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine less than or equal to 1.5 times upper limits of normal institutional limits",
                        "criterion": "Creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limits of normal institutional limits"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "leukocytes greater than or equal to 3,000/mL",
                        "criterion": "leukocytes",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "absolute neutrophil count greater than or equal to 1,500/mL",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platelets greater than or equal to 100,000/mL",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "total bilirubin less than or equal to 1.5 times upper limits of normal institutional limits",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limits of normal institutional limits"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST(SGOT) less than or equal to 3 X ULN",
                        "criterion": "AST(SGOT)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT(SGPT) less than or equal to 3 X ULN",
                        "criterion": "ALT(SGPT)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Creatinine less than or equal to 1.5 times upper limits of normal institutional limits",
                        "criterion": "Creatinine",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times upper limits of normal institutional limits"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Patients with a prior history of non-colorectal cancer who have no active disease may be eligible if they are disease free for greater than or equal to 12 months prior to treatment.",
                "criterions": [
                    {
                        "exact_snippets": "prior history of non-colorectal cancer",
                        "criterion": "prior history of non-colorectal cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no active disease",
                        "criterion": "active disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "disease free for greater than or equal to 12 months",
                        "criterion": "disease-free period",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "prior history of non-colorectal cancer",
                            "criterion": "prior history of non-colorectal cancer",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "no active disease",
                            "criterion": "active disease",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "disease free for greater than or equal to 12 months",
                    "criterion": "disease-free period",
                    "requirement": {
                        "requirement_type": "duration",
                        "expected_value": {
                            "operator": ">=",
                            "value": 12,
                            "unit": "months"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "8. The effects of SIR-Spheres, irinotecan or cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radiation as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately.",
                "criterions": [
                    {
                        "exact_snippets": "women of child-bearing potential",
                        "criterion": "child-bearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "men must agree to use adequate contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "women of child-bearing potential ... must agree to use adequate contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Should a woman become pregnant or suspect she is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "women of child-bearing potential",
                                        "criterion": "child-bearing potential",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "women of child-bearing potential ... must agree to use adequate contraception",
                                        "criterion": "contraception use",
                                        "requirement": {
                                            "requirement_type": "agreement",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "men must agree to use adequate contraception",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Should a woman become pregnant or suspect she is pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Ability to understand and the willingness to sign a written informed consent document.",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Patients without evidence of local disease recurrence from colorectal cancer are eligible",
                "criterions": [
                    {
                        "exact_snippets": "without evidence of local disease recurrence from colorectal cancer",
                        "criterion": "local disease recurrence from colorectal cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "without evidence of local disease recurrence from colorectal cancer",
                        "criterion": "local disease recurrence from colorectal cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Patients with extrahepatic disease confined to the lung is permitted if < 4 lesions are depicted on CTand all are < 3 cm in size",
                "criterions": [
                    {
                        "exact_snippets": "extrahepatic disease confined to the lung",
                        "criterion": "extrahepatic disease location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "lung"
                        }
                    },
                    {
                        "exact_snippets": "< 4 lesions are depicted on CT",
                        "criterion": "number of lesions",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "lesions"
                            }
                        }
                    },
                    {
                        "exact_snippets": "all are < 3 cm in size",
                        "criterion": "lesion size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "extrahepatic disease confined to the lung",
                                "criterion": "extrahepatic disease location",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "lung"
                                }
                            },
                            {
                                "exact_snippets": "< 4 lesions are depicted on CT",
                                "criterion": "number of lesions",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "lesions"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "all are < 3 cm in size",
                        "criterion": "lesion size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Patients with brain mets are eligible for this trial if those patients who have had the area surgically resected or irradiated and have no evidence of active disease as demonstrated by MRI of the brain. Patients must have no evidence of residual neurological dysfunction as per baseline neurological exam. Patients with untreated brain metastases will be considered ineligible.",
                "criterions": [
                    {
                        "exact_snippets": "Patients with brain mets are eligible ... if those patients who have had the area surgically resected or irradiated",
                        "criterion": "brain metastases treatment",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "surgically resected",
                                "irradiated"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "no evidence of active disease as demonstrated by MRI of the brain",
                        "criterion": "active brain disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must have no evidence of residual neurological dysfunction as per baseline neurological exam",
                        "criterion": "residual neurological dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients with untreated brain metastases will be considered ineligible",
                        "criterion": "untreated brain metastases",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Patients with brain mets are eligible ... if those patients who have had the area surgically resected or irradiated",
                                        "criterion": "brain metastases treatment",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": [
                                                "surgically resected",
                                                "irradiated"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Patients with untreated brain metastases will be considered ineligible",
                                        "criterion": "untreated brain metastases",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "no evidence of active disease as demonstrated by MRI of the brain",
                                "criterion": "active brain disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Patients must have no evidence of residual neurological dysfunction as per baseline neurological exam",
                        "criterion": "residual neurological dysfunction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier will be excluded. Patients who have had hepatic external beam radiotherapy will be excluded.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study",
                        "criterion": "recent chemotherapy",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study",
                        "criterion": "recent chemotherapy with nitrosoureas or mitomycin C",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "those who have not recovered from adverse events due to agents administered more than 4 weeks earlier",
                        "criterion": "recovery from adverse events",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Patients who have had hepatic external beam radiotherapy will be excluded",
                        "criterion": "hepatic external beam radiotherapy",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study",
                                        "criterion": "recent chemotherapy",
                                        "requirement": {
                                            "requirement_type": "time since treatment",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 4,
                                                        "unit": "weeks"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "those who have not recovered from adverse events due to agents administered more than 4 weeks earlier",
                                        "criterion": "recovery from adverse events",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study",
                                        "criterion": "recent chemotherapy with nitrosoureas or mitomycin C",
                                        "requirement": {
                                            "requirement_type": "time since treatment",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": "<=",
                                                        "value": 6,
                                                        "unit": "weeks"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "those who have not recovered from adverse events due to agents administered more than 4 weeks earlier",
                                        "criterion": "recovery from adverse events",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Patients who have had hepatic external beam radiotherapy will be excluded",
                        "criterion": "hepatic external beam radiotherapy",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients may not be receiving any other investigational agents.",
                "criterions": [
                    {
                        "exact_snippets": "Patients may not be receiving any other investigational agents.",
                        "criterion": "receiving investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients may not be receiving any other investigational agents.",
                        "criterion": "receiving investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to SIR-Spheres, irinotecan or cetuximab or other agents used in the study.",
                "criterions": [
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to SIR-Spheres",
                        "criterion": "allergic reactions to SIR-Spheres",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... irinotecan",
                        "criterion": "allergic reactions to irinotecan",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... cetuximab",
                        "criterion": "allergic reactions to cetuximab",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... other agents used in the study",
                        "criterion": "allergic reactions to other agents used in the study",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to SIR-Spheres",
                                "criterion": "allergic reactions to SIR-Spheres",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... irinotecan",
                                "criterion": "allergic reactions to irinotecan",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... cetuximab",
                                "criterion": "allergic reactions to cetuximab",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to ... other agents used in the study",
                                "criterion": "allergic reactions to other agents used in the study",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Evidence of ascites, biopsy proven cirrhosis or portal hypertension suggested by the presence of characteristic imaging features on cross sectional imaging or esophageal varicosities demonstrated on endoscopy or barium swallow. A diagnostic study to rule out the presence of portal hypertension will not be required unless the findings on cross sectional imaging are suggestive but not confirmatory.",
                "criterions": [
                    {
                        "exact_snippets": "Evidence of ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "biopsy proven cirrhosis",
                        "criterion": "cirrhosis",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "biopsy proven"
                        }
                    },
                    {
                        "exact_snippets": "portal hypertension suggested by the presence of characteristic imaging features on cross sectional imaging",
                        "criterion": "portal hypertension",
                        "requirement": {
                            "requirement_type": "suggestion",
                            "expected_value": "characteristic imaging features on cross sectional imaging"
                        }
                    },
                    {
                        "exact_snippets": "esophageal varicosities demonstrated on endoscopy or barium swallow",
                        "criterion": "esophageal varicosities",
                        "requirement": {
                            "requirement_type": "demonstration",
                            "expected_value": [
                                "endoscopy",
                                "barium swallow"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "portal hypertension suggested by the presence of characteristic imaging features on cross sectional imaging",
                                "criterion": "portal hypertension",
                                "requirement": {
                                    "requirement_type": "suggestion",
                                    "expected_value": "characteristic imaging features on cross sectional imaging"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "esophageal varicosities demonstrated on endoscopy or barium swallow",
                                        "criterion": "esophageal varicosities",
                                        "requirement": {
                                            "requirement_type": "demonstration",
                                            "expected_value": [
                                                "endoscopy",
                                                "barium swallow"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "biopsy proven cirrhosis",
                                        "criterion": "cirrhosis",
                                        "requirement": {
                                            "requirement_type": "confirmation",
                                            "expected_value": "biopsy proven"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Evidence of ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Hepatic arterial anatomy that would prevent catheterization and the administration of SIR-Spheres into the liver.",
                "criterions": [
                    {
                        "exact_snippets": "Hepatic arterial anatomy that would prevent catheterization and the administration of SIR-Spheres into the liver",
                        "criterion": "hepatic arterial anatomy",
                        "requirement": {
                            "requirement_type": "suitability for catheterization and administration",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hepatic arterial anatomy that would prevent catheterization and the administration of SIR-Spheres into the liver",
                        "criterion": "hepatic arterial anatomy",
                        "requirement": {
                            "requirement_type": "suitability for catheterization and administration",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospital admission or antibiotics,symptomatic congestive heart failure (class III and IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations would exclude patients from this study.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospital admission or antibiotics",
                        "criterion": "uncontrolled intercurrent illness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ongoing or active infection requiring hospital admission or antibiotics",
                        "criterion": "ongoing or active infection",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "requiring hospital admission or antibiotics"
                        }
                    },
                    {
                        "exact_snippets": "symptomatic congestive heart failure (class III and IV)",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "symptomatic (class III and IV)"
                        }
                    },
                    {
                        "exact_snippets": "unstable angina pectoris",
                        "criterion": "angina pectoris",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    },
                    {
                        "exact_snippets": "cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "psychiatric illness/social situations",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospital admission or antibiotics",
                                "criterion": "uncontrolled intercurrent illness",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "ongoing or active infection requiring hospital admission or antibiotics",
                                "criterion": "ongoing or active infection",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "requiring hospital admission or antibiotics"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "symptomatic congestive heart failure (class III and IV)",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "symptomatic (class III and IV)"
                        }
                    },
                    {
                        "exact_snippets": "unstable angina pectoris",
                        "criterion": "angina pectoris",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    },
                    {
                        "exact_snippets": "cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "psychiatric illness/social situations",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Contraindications to angiography and selective visceral catheterization: History of severe allergy or intolerance to any contrast media, or atropine. Bleeding diathesis, not correctable by usual forms of therapy that would include medical coagulopathy but not limited to the administration of blood products.",
                "criterions": [
                    {
                        "exact_snippets": "History of severe allergy or intolerance to any contrast media",
                        "criterion": "severe allergy or intolerance to contrast media",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of severe allergy or intolerance to ... atropine",
                        "criterion": "severe allergy or intolerance to atropine",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Bleeding diathesis, not correctable by usual forms of therapy",
                        "criterion": "bleeding diathesis",
                        "requirement": {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "History of severe allergy or intolerance to any contrast media",
                                "criterion": "severe allergy or intolerance to contrast media",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of severe allergy or intolerance to ... atropine",
                                "criterion": "severe allergy or intolerance to atropine",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Bleeding diathesis, not correctable by usual forms of therapy",
                        "criterion": "bleeding diathesis",
                        "requirement": {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Utilization of capecitabine for the 6 weeks preceding SIR-Sphere therapy and indefinitely following SIR-Sphere therapy as per manufacturer's recommendations due to the increased risk of radiation hepatitis.",
                "criterions": [
                    {
                        "exact_snippets": "Utilization of capecitabine for the 6 weeks preceding SIR-Sphere therapy",
                        "criterion": "capecitabine utilization",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Utilization of capecitabine ... indefinitely following SIR-Sphere therapy",
                        "criterion": "capecitabine utilization",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "indefinitely"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Utilization of capecitabine for the 6 weeks preceding SIR-Sphere therapy",
                                "criterion": "capecitabine utilization",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "=",
                                                "value": 6,
                                                "unit": "weeks"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Utilization of capecitabine ... indefinitely following SIR-Sphere therapy",
                                "criterion": "capecitabine utilization",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": "indefinitely"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Patients exhibiting the mutant variety for kras will be excluded for participation in the study.",
                "criterions": [
                    {
                        "exact_snippets": "mutant variety for kras",
                        "criterion": "kras mutation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "mutant variety for kras",
                    "criterion": "kras mutation",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1. Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Histology from the hepatic metastasis is not mandatory if the morphological appearances on cross sectional imaging and tumor markers (CEA) are indicative of a colorectal primary.",
                "criterions": [
                    {
                        "exact_snippets": "histologically or cytologically confirmed adenocarcinoma of the colon or rectum",
                        "criterion": "adenocarcinoma of the colon or rectum",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Histology from the hepatic metastasis is not mandatory",
                        "criterion": "histology from hepatic metastasis",
                        "requirement": {
                            "requirement_type": "mandatory",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "morphological appearances on cross sectional imaging and tumor markers (CEA) are indicative of a colorectal primary",
                        "criterion": "colorectal primary indication",
                        "requirement": {
                            "requirement_type": "indication methods",
                            "expected_value": [
                                "morphological appearances on cross sectional imaging",
                                "tumor markers (CEA)"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "histologically or cytologically confirmed adenocarcinoma of the colon or rectum",
                                    "criterion": "adenocarcinoma of the colon or rectum",
                                    "requirement": {
                                        "requirement_type": "confirmation method",
                                        "expected_value": [
                                            "histologically",
                                            "cytologically"
                                        ]
                                    }
                                },
                                {
                                    "exact_snippets": "histology from the hepatic metastasis is not mandatory",
                                    "criterion": "histology from hepatic metastasis",
                                    "requirement": {
                                        "requirement_type": "mandatory",
                                        "expected_value": false
                                    }
                                }
                            ]
                        },
                        {
                            "exact_snippets": "morphological appearances on cross sectional imaging and tumor markers (CEA) are indicative of a colorectal primary",
                            "criterion": "colorectal primary indication",
                            "requirement": {
                                "requirement_type": "indication methods",
                                "expected_value": [
                                    "morphological appearances on cross sectional imaging",
                                    "tumor markers (CEA)"
                                ]
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "histologically or cytologically confirmed adenocarcinoma of the colon or rectum",
                    "criterion": "adenocarcinoma of the colon or rectum",
                    "requirement": {
                        "requirement_type": "confirmation method",
                        "expected_value": [
                            "histologically",
                            "cytologically"
                        ]
                    }
                }
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}