{
    "info": {
        "nct_id": "NCT00860860",
        "official_title": "Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal Cancer",
        "inclusion_criteria": "* Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available\n* WHO performance status: 0 or 1\n* Having normal hematological function: Neutrophils > 1.5 x 109/l; Platelet count > 150 x 109/l, without transfusion during the previous month; Hemoglobin > 5.6 mmol/l\n* Total bilirubin < 2 x upper limit of normal (ULN)\n* ASAT, ALAT < 3 x ULN\n* Serum creatinine < 2 x ULN\n* Cockcroft clearance > 50 ml/min\n* Negative pregnancy test for women of child¬bearing potential (urine or serum)\n* Age over 18 years\n* Ability to provide written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Known metastases to the brain\n* Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.\n* Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks\n* Cardiac disease with New York Heart Association classification of III or IV\n* Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception\n* Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status\n* Life expectancy shorter than 6 months.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available",
            "criterions": [
                {
                    "exact_snippets": "CEA expressing advanced colorectal tumors",
                    "criterion": "CEA expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced colorectal tumors",
                    "criterion": "advanced colorectal tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard treatment is available",
                    "criterion": "standard treatment availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance status: 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status: 0 or 1",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having normal hematological function: Neutrophils > 1.5 x 109/l; Platelet count > 150 x 109/l, without transfusion during the previous month; Hemoglobin > 5.6 mmol/l",
            "criterions": [
                {
                    "exact_snippets": "Neutrophils > 1.5 x 109/l",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x 10^9/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count > 150 x 109/l, without transfusion during the previous month",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "x 10^9/l"
                            }
                        },
                        {
                            "requirement_type": "transfusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin > 5.6 mmol/l",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5.6,
                                "unit": "mmol/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin < 2 x upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin < 2 x upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ASAT, ALAT < 3 x ULN",
            "criterions": [
                {
                    "exact_snippets": "ASAT, ALAT < 3 x ULN",
                    "criterion": "ASAT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ASAT, ALAT < 3 x ULN",
                    "criterion": "ALAT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine < 2 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine < 2 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cockcroft clearance > 50 ml/min",
            "criterions": [
                {
                    "exact_snippets": "Cockcroft clearance > 50 ml/min",
                    "criterion": "Cockcroft clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test for women of child¬bearing potential (urine or serum)",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test for women of child¬bearing potential (urine or serum)",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age over 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age over 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to provide written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Known metastases to the brain",
            "criterions": [
                {
                    "exact_snippets": "Known metastases to the brain",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy ... within 4 weeks prior to study.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "external beam radiation ... within 4 weeks prior to study.",
                    "criterion": "external beam radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy within 4 weeks prior to study.",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.",
                    "criterion": "limited field external beam radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "prevent pathological fractures"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "unirradiated, evaluable lesions elsewhere are present"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks",
            "criterions": [
                {
                    "exact_snippets": "Prior angiogenesis inhibitors within 4 weeks",
                    "criterion": "prior angiogenesis inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bevacizumab within 8 weeks",
                    "criterion": "prior bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac disease with New York Heart Association classification of III or IV",
            "criterions": [
                {
                    "exact_snippets": "Cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association classification of III or IV",
                    "criterion": "New York Heart Association classification",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception",
            "criterions": [
                {
                    "exact_snippets": "Patients who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "of reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not practicing an effective method of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status",
            "criterions": [
                {
                    "exact_snippets": "active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammation",
                    "criterion": "inflammation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormalities",
                    "criterion": "laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy shorter than 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy shorter than 6 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}