{
    "info": {
        "nct_id": "NCT00716391",
        "official_title": "Open Label Randomized, Multi-centre Phase III Trial of TPF Plus Concomitant Treatment With Cisplatin and Radiotherapy Versus Concomitant Cetuximab and Radiotherapy in Locally Advanced, Unresectable Head and Neck Cancer.",
        "inclusion_criteria": "1. Before the beginning of protocol's specific procedures, the informed consent has to be obtained.\n2. Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and hypopharynx) stage III-IV, without evidence of metastasis.\n3. The tumor must be considered to be non-operable according to the criteria of the Northern California Oncology Group. The reason of non-surgical resection will be annotated in the CRF.\n\n   Criteria of non-surgical resection according to the NCOG:\n\n   3.1.Technically not resectable (includes: evidence of mediastinal dissemination; fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation of the nasopharynx).\n\n   3.2.Medical criteria based on a low surgical curability. 3.3.Medical contraindication for the surgery.\n4. Epidermoid carcinoma histologically demonstrated\n5. Measurable disease according to the RECIST criteria .\n6. Men or women with age between 18 and 70 years, both inclusive.\n7. Functional condition index according to ECOG scale:0-1\n8. Patients in medical conditions to be able to receive treatment with TPF induction followed by normofractionated radiotherapy with cetuximab or cisplatin.\n9. Patients with adequate hematologic function: neutrophils superior or equal to 2 x 109, platelets superior or equal to 100 x 109, hemoglobin superior or equal to 10 g/dl.\n10. Adequate hepatic function: bilirubin lower or equal to 1 x top normal Limit, GOT and GPT lower or equal to 2,5 Top Normal Limit , alkaline phosphatase < 5 Top Normal Limit.\n11. Adequate renal function: creatinin <1,4 mg/dl (120 µmol/l); if the values are > 1,4 mg/dl, the clearance of creatinin will have to be > 60 ml/min (real or calculated for Cockcroft-Gault's method).\n12. Calcium lower or equal to 1,25 x top normal limit.\n13. Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.\n14. Patients must be accessible for the treatment and the follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Metastatic disease\n2. Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.\n3. Other tumor locations in head and neck that are not oral cavity, oropharynx, larynx, hypopharynx.\n4. Other stages that are not III or IVM0.\n5. Other previous and / or synchronic squamous carcinoma.\n6. Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.\n7. Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.\n8. Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and / or diastolic arterial tension superior or equal to 130 mm Hg baseline.\n9. Pregnancy(absence must be confirmed with the test of beta-HCG) or period of lactation.\n10. Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.\n11. Other antineoplastic concomitant treatments.\n12. Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency.\n13. Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.\n14. Active non controlled peptic ulcer.\n15. Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form.\n16. Known drugs abuse (with the exception of excessive consumption of alcohol)\n17. Known allergic reaction to some of the components of the treatment of the study.\n18. Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.\n19. Any experimental treatment in 30 days before the entry in the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Before the beginning of protocol's specific procedures, the informed consent has to be obtained.",
            "criterions": [
                {
                    "exact_snippets": "informed consent has to be obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "obtained",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and hypopharynx) stage III-IV, without evidence of metastasis.",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and hypopharynx)",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "larynx",
                                "hypopharynx"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "stage III-IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without evidence of metastasis",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. The tumor must be considered to be non-operable according to the criteria of the Northern California Oncology Group. The reason of non-surgical resection will be annotated in the CRF.",
            "criterions": [
                {
                    "exact_snippets": "The tumor must be considered to be non-operable",
                    "criterion": "tumor operability",
                    "requirements": [
                        {
                            "requirement_type": "operability",
                            "expected_value": "non-operable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Criteria of non-surgical resection according to the NCOG:",
            "criterions": [
                {
                    "exact_snippets": "non-surgical resection",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3.1.Technically not resectable (includes: evidence of mediastinal dissemination; fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation of the nasopharynx).",
            "criterions": [
                {
                    "exact_snippets": "Technically not resectable ... evidence of mediastinal dissemination",
                    "criterion": "mediastinal dissemination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Technically not resectable ... fixed tumor to the clavicle",
                    "criterion": "fixed tumor to the clavicle",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Technically not resectable ... fixed tumor to the ... base of the cranium",
                    "criterion": "fixed tumor to the base of the cranium",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Technically not resectable ... fixed tumor to the ... cervical vertebrae",
                    "criterion": "fixed tumor to the cervical vertebrae",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Technically not resectable ... affectation of the nasopharynx",
                    "criterion": "affectation of the nasopharynx",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3.2.Medical criteria based on a low surgical curability. 3.3.Medical contraindication for the surgery.",
            "criterions": [
                {
                    "exact_snippets": "low surgical curability",
                    "criterion": "surgical curability",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "Medical contraindication for the surgery",
                    "criterion": "surgery contraindication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Epidermoid carcinoma histologically demonstrated",
            "criterions": [
                {
                    "exact_snippets": "Epidermoid carcinoma histologically demonstrated",
                    "criterion": "epidermoid carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically demonstrated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Measurable disease according to the RECIST criteria .",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease according to the RECIST criteria",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Men or women with age between 18 and 70 years, both inclusive.",
            "criterions": [
                {
                    "exact_snippets": "Men or women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "age between 18 and 70 years, both inclusive",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Functional condition index according to ECOG scale:0-1",
            "criterions": [
                {
                    "exact_snippets": "Functional condition index according to ECOG scale:0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients in medical conditions to be able to receive treatment with TPF induction followed by normofractionated radiotherapy with cetuximab or cisplatin.",
            "criterions": [
                {
                    "exact_snippets": "Patients in medical conditions to be able to receive treatment with TPF induction",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "ability to receive treatment",
                            "expected_value": "TPF induction"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients in medical conditions to be able to receive treatment ... followed by normofractionated radiotherapy with cetuximab or cisplatin",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "ability to receive treatment",
                            "expected_value": "normofractionated radiotherapy with cetuximab or cisplatin"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with adequate hematologic function: neutrophils superior or equal to 2 x 109, platelets superior or equal to 100 x 109, hemoglobin superior or equal to 10 g/dl.",
            "criterions": [
                {
                    "exact_snippets": "neutrophils superior or equal to 2 x 109",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "x 10^9"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets superior or equal to 100 x 109",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin superior or equal to 10 g/dl",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Adequate hepatic function: bilirubin lower or equal to 1 x top normal Limit, GOT and GPT lower or equal to 2,5 Top Normal Limit , alkaline phosphatase < 5 Top Normal Limit.",
            "criterions": [
                {
                    "exact_snippets": "bilirubin lower or equal to 1 x top normal Limit",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "x top normal Limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "GOT and GPT lower or equal to 2,5 Top Normal Limit",
                    "criterion": "GOT and GPT levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "Top Normal Limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase < 5 Top Normal Limit",
                    "criterion": "alkaline phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "Top Normal Limit"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Adequate renal function: creatinin <1,4 mg/dl (120 µmol/l); if the values are > 1,4 mg/dl, the clearance of creatinin will have to be > 60 ml/min (real or calculated for Cockcroft-Gault's method).",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function: creatinin <1,4 mg/dl (120 µmol/l)",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.4,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if the values are > 1,4 mg/dl, the clearance of creatinin will have to be > 60 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Calcium lower or equal to 1,25 x top normal limit.",
            "criterions": [
                {
                    "exact_snippets": "Calcium lower or equal to 1,25 x top normal limit.",
                    "criterion": "calcium level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.25,
                                "unit": "x top normal limit"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.",
            "criterions": [
                {
                    "exact_snippets": "Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 20,
                                "unit": "% of theoretical weight"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate nutritional condition: ... albumin superior or equal to 35 g/L.",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 35,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patients must be accessible for the treatment and the follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be accessible for the treatment",
                    "criterion": "patient accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must be accessible for ... the follow-up",
                    "criterion": "patient accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.",
            "criterions": [
                {
                    "exact_snippets": "Surgical treatment",
                    "criterion": "surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Other tumor locations in head and neck that are not oral cavity, oropharynx, larynx, hypopharynx.",
            "criterions": [
                {
                    "exact_snippets": "Other tumor locations in head and neck",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "head and neck"
                        }
                    ]
                },
                {
                    "exact_snippets": "not oral cavity, oropharynx, larynx, hypopharynx",
                    "criterion": "tumor location exclusion",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "larynx",
                                "hypopharynx"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Other stages that are not III or IVM0.",
            "criterions": [
                {
                    "exact_snippets": "Other stages that are not III or IVM0",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "III",
                                "IVM0"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Other previous and / or synchronic squamous carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Other previous and / or synchronic squamous carcinoma.",
                    "criterion": "squamous carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of another neoplasia in the last 5 years",
                    "criterion": "another neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excepting carcinoma in situ of uterine neck",
                    "criterion": "carcinoma in situ of uterine neck",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "excepting ... a cutaneous carcinoma basocellular properly treated",
                    "criterion": "cutaneous carcinoma basocellular",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "properly treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.",
            "criterions": [
                {
                    "exact_snippets": "Active infection(at needs endovenous antibiotics)",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "endovenous antibiotics"
                        }
                    ]
                },
                {
                    "exact_snippets": "active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed HIV",
                    "criterion": "HIV",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and / or diastolic arterial tension superior or equal to 130 mm Hg baseline.",
            "criterions": [
                {
                    "exact_snippets": "Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg",
                    "criterion": "arterial systolic tension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 180,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Not controlled hypertension defined as ... diastolic arterial tension superior or equal to 130 mm Hg",
                    "criterion": "diastolic arterial tension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 130,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Pregnancy(absence must be confirmed with the test of beta-HCG) or period of lactation.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy(absence must be confirmed with the test of beta-HCG)",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "period of lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.",
            "criterions": [
                {
                    "exact_snippets": "Immunity systemic treatment",
                    "criterion": "immunity systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic and concomitant",
                    "criterion": "chronic and concomitant treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hormonal treatment of the cancer",
                    "criterion": "hormonal treatment of the cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Other antineoplastic concomitant treatments.",
            "criterions": [
                {
                    "exact_snippets": "Other antineoplastic concomitant treatments.",
                    "criterion": "antineoplastic concomitant treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency.",
            "criterions": [
                {
                    "exact_snippets": "Coronary clinically significant arteriopathy",
                    "criterion": "coronary arteriopathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "precedents of myocardial infarction in the last 12 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "in the last 12 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "high risk of not controlled arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac not controlled insufficiency",
                    "criterion": "cardiac insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.",
            "criterions": [
                {
                    "exact_snippets": "Pulmonary obstructive chronic disease",
                    "criterion": "pulmonary obstructive chronic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "3 or more hospitalizations in the last 12 months",
                    "criterion": "hospitalizations",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "hospitalizations"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "last 12 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Active non controlled peptic ulcer.",
            "criterions": [
                {
                    "exact_snippets": "Active non controlled peptic ulcer",
                    "criterion": "peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Presence of a psychological or medical disease",
                    "criterion": "psychological or medical disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "could prevent to accomplish the study",
                    "criterion": "ability to accomplish the study",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "to grant his/her signature in the informed consent form",
                    "criterion": "ability to grant signature in informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Known drugs abuse (with the exception of excessive consumption of alcohol)",
            "criterions": [
                {
                    "exact_snippets": "Known drugs abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Known allergic reaction to some of the components of the treatment of the study.",
            "criterions": [
                {
                    "exact_snippets": "Known allergic reaction to some of the components of the treatment",
                    "criterion": "allergic reaction to treatment components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with monoclonal antibodies",
                    "criterion": "previous treatment with monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with ... other transduction of the sign inhibitors",
                    "criterion": "previous treatment with transduction of the sign inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous treatment with ... treatment directed against the EGFR",
                    "criterion": "previous treatment directed against the EGFR",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Any experimental treatment in 30 days before the entry in the study.",
            "criterions": [
                {
                    "exact_snippets": "Any experimental treatment in 30 days before the entry in the study.",
                    "criterion": "experimental treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}