{
    "info": {
        "nct_id": "NCT05665920",
        "official_title": "Clinical Trial to Assess the Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy",
        "inclusion_criteria": "* Information to the patient and signed informed consent;\n* Women aged ≥18 years;\n* Breast conserving surgery;\n* Invasive adenocarcinoma (except classic invasive lobular carcinoma);\n* TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;\n* Eastern Cooperative Oncology Group (ECOG) 0 -1;\n* Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);\n* No previous breast or mediastinal radiotherapy;\n* No hematogenous metastases;\n* Ability to carry out long-term follow-up;\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Previous local irradiation;\n* Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;\n* Histology of metaplastic carcinoma;\n* History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.\n* Diagnosis of autoimmune and connective tissue diseases;\n* Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);\n* Indication of internal breast irradiation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Information to the patient and signed informed consent;",
                "criterions": [
                    {
                        "exact_snippets": "Information to the patient and signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Information to the patient and signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Women aged ≥18 years;",
                "criterions": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "aged ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "aged ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Breast conserving surgery;",
                "criterions": [
                    {
                        "exact_snippets": "Breast conserving surgery",
                        "criterion": "breast conserving surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Breast conserving surgery",
                        "criterion": "breast conserving surgery",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;",
                "criterions": [
                    {
                        "exact_snippets": "TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3",
                        "criterion": "tumor pathologic stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "pT"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "pT"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "TNM (Tumor, Nodes, Metastasis) pathologic stage ... pN1-3a",
                        "criterion": "nodes pathologic stage",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "pN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "pN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "TNM (Tumor, Nodes, Metastasis) pathologic stage ... M0",
                        "criterion": "metastasis pathologic stage",
                        "requirement": {
                            "requirement_type": "exact",
                            "expected_value": "M0"
                        }
                    },
                    {
                        "exact_snippets": "indication of lymphatic drainage according to institutional protocol",
                        "criterion": "lymphatic drainage indication",
                        "requirement": {
                            "requirement_type": "protocol adherence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3",
                                        "criterion": "tumor pathologic stage",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 1,
                                                        "unit": "pT"
                                                    },
                                                    {
                                                        "operator": "<=",
                                                        "value": 3,
                                                        "unit": "pT"
                                                    }
                                                ]
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "TNM (Tumor, Nodes, Metastasis) pathologic stage ... pN1-3a",
                                        "criterion": "nodes pathologic stage",
                                        "requirement": {
                                            "requirement_type": "range",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 1,
                                                        "unit": "pN"
                                                    },
                                                    {
                                                        "operator": "<=",
                                                        "value": 3,
                                                        "unit": "pN"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "TNM (Tumor, Nodes, Metastasis) pathologic stage ... M0",
                                "criterion": "metastasis pathologic stage",
                                "requirement": {
                                    "requirement_type": "exact",
                                    "expected_value": "M0"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "indication of lymphatic drainage according to institutional protocol",
                        "criterion": "lymphatic drainage indication",
                        "requirement": {
                            "requirement_type": "protocol adherence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) 0 -1;",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) 0 -1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) 0 -1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);",
                "criterions": [
                    {
                        "exact_snippets": "Minimum microscopic margin of non-cancerous tissue of 2 mm",
                        "criterion": "microscopic margin of non-cancerous tissue",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Minimum microscopic margin of non-cancerous tissue of 2 mm",
                        "criterion": "microscopic margin of non-cancerous tissue",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "excluding deep margin if in the deep fascia",
                            "criterion": "deep margin in the deep fascia",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": true
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No previous breast or mediastinal radiotherapy;",
                "criterions": [
                    {
                        "exact_snippets": "No previous breast ... radiotherapy",
                        "criterion": "previous breast radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No previous ... mediastinal radiotherapy",
                        "criterion": "previous mediastinal radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No previous breast ... radiotherapy",
                        "criterion": "previous breast radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No previous ... mediastinal radiotherapy",
                        "criterion": "previous mediastinal radiotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No hematogenous metastases;",
                "criterions": [
                    {
                        "exact_snippets": "No hematogenous metastases",
                        "criterion": "hematogenous metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No hematogenous metastases",
                        "criterion": "hematogenous metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ability to carry out long-term follow-up;",
                "criterions": [
                    {
                        "exact_snippets": "Ability to carry out long-term follow-up",
                        "criterion": "ability to carry out long-term follow-up",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to carry out long-term follow-up",
                        "criterion": "ability to carry out long-term follow-up",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "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 be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "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": "* Previous local irradiation;",
                "criterions": [
                    {
                        "exact_snippets": "Previous local irradiation",
                        "criterion": "local irradiation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous local irradiation",
                        "criterion": "local irradiation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;",
                "criterions": [
                    {
                        "exact_snippets": "Concomitant chemotherapy",
                        "criterion": "concomitant chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Concomitance with trastuzumab ... will be allowed",
                        "criterion": "concomitance with trastuzumab",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Concomitance with ... hormone blockade will be allowed",
                        "criterion": "concomitance with hormone blockade",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Concomitant chemotherapy",
                                    "criterion": "concomitant chemotherapy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "Concomitance with trastuzumab ... will be allowed",
                                                "criterion": "concomitance with trastuzumab",
                                                "requirement": {
                                                    "requirement_type": "allowance",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "Concomitance with ... hormone blockade will be allowed",
                                                "criterion": "concomitance with hormone blockade",
                                                "requirement": {
                                                    "requirement_type": "allowance",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Histology of metaplastic carcinoma;",
                "criterions": [
                    {
                        "exact_snippets": "Histology of metaplastic carcinoma",
                        "criterion": "histology",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "metaplastic carcinoma"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Histology of metaplastic carcinoma",
                    "criterion": "histology",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": "metaplastic carcinoma"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.",
                "criterions": [
                    {
                        "exact_snippets": "History of another neoplasm: non-melanoma skin cancer",
                        "criterion": "history of non-melanoma skin cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "History of another neoplasm: ... carcinoma in situ of the uterine cervix",
                        "criterion": "history of carcinoma in situ of the uterine cervix",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed",
                        "criterion": "another neoplasm treated with curative intent",
                        "requirement": {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed",
                        "criterion": "another neoplasm treated with curative intent",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "History of another neoplasm: non-melanoma skin cancer",
                                "criterion": "history of non-melanoma skin cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "History of another neoplasm: ... carcinoma in situ of the uterine cervix",
                                "criterion": "history of carcinoma in situ of the uterine cervix",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed",
                                    "criterion": "another neoplasm treated with curative intent",
                                    "requirement": {
                                        "requirement_type": "evidence of disease",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed",
                                    "criterion": "another neoplasm treated with curative intent",
                                    "requirement": {
                                        "requirement_type": "time since treatment",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 5,
                                            "unit": "years"
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Diagnosis of autoimmune and connective tissue diseases;",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of autoimmune and connective tissue diseases",
                        "criterion": "autoimmune diseases",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis of autoimmune and connective tissue diseases",
                        "criterion": "connective tissue diseases",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Diagnosis of autoimmune and connective tissue diseases",
                        "criterion": "autoimmune diseases",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Diagnosis of autoimmune and connective tissue diseases",
                        "criterion": "connective tissue diseases",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia)",
                        "criterion": "genetic alterations in cell repair genes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia)",
                    "criterion": "genetic alterations in cell repair genes",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Indication of internal breast irradiation.",
                "criterions": [
                    {
                        "exact_snippets": "Indication of internal breast irradiation",
                        "criterion": "internal breast irradiation",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Indication of internal breast irradiation",
                        "criterion": "internal breast irradiation",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Invasive adenocarcinoma (except classic invasive lobular carcinoma);",
                "criterions": [
                    {
                        "exact_snippets": "Invasive adenocarcinoma",
                        "criterion": "adenocarcinoma",
                        "requirement": {
                            "requirement_type": "invasiveness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except classic invasive lobular carcinoma",
                        "criterion": "classic invasive lobular carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Invasive adenocarcinoma",
                                "criterion": "adenocarcinoma",
                                "requirement": {
                                    "requirement_type": "invasiveness",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "except classic invasive lobular carcinoma",
                                    "criterion": "classic invasive lobular carcinoma",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}