{
    "info": {
        "nct_id": "NCT04228991",
        "official_title": "Randomized Trial of Hypofractionated LocoRegional Radiotherapy in Breast Cancer and Lymphedema (RHEAL)",
        "inclusion_criteria": "1. Newly diagnosed invasive carcinoma of the breast.\n2. Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.* Note: *Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible.\n3. Candidate for locoregional radiotherapy: breast cancer stage after definitive surgery:\n\n   * Neoadjuvant chemotherapy was not administered: pathologic stage T3N0,T1-3 N1-2**\n\n     ** patients with nodal micromets (N1mi) are eligible\n   * Neoadjuvant chemotherapy was administered: clinical stage T3N0, T1-3, N1-2 and pathologic stage T0-3, N0-2†\n\n     * Patients who are clinically N1-2 prior to chemotherapy should be confirmed histologically unless it is clear that they are node positive. Patients who are deemed node negative prior to chemotherapy but are node positive following chemotherapy are eligible. Patients who are node positive prior to chemotherapy and who have complete response in the lymph nodes are also eligible.\n4. No evidence of metastatic disease.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Age < 18 years.\n2. Clinical stages T4 and/or N3.\n3. Clinical lymphedema in the ipsilateral arm or breast/chest wall.\n4. Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with previous ipsilateral DCIS or LCIS not treated with radiation are eligible.)\n5. Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.)\n6. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.\n7. Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.)\n8. Breast reconstruction.\n9. Presence of known medical conditions that would preclude follow-up for 5 years.\n10. Previous radiotherapy to the ipsilateral breast or chest wall or serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy.\n11. Known pregnancy or currently lactating.\n12. Geographic inaccessibility for follow-up.\n13. Inability to provide informed consent.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Newly diagnosed invasive carcinoma of the breast.",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed invasive carcinoma of the breast",
                    "criterion": "invasive carcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.* Note: *Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND)",
                    "criterion": "definitive surgery",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "BCS",
                                "mastectomy"
                            ]
                        },
                        {
                            "requirement_type": "nodal staging",
                            "expected_value": [
                                "SLNB",
                                "ALND"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "clear margins of excision",
                    "criterion": "margins of excision",
                    "requirements": [
                        {
                            "requirement_type": "clarity",
                            "expected_value": "clear"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Candidate for locoregional radiotherapy: breast cancer stage after definitive surgery:",
            "criterions": [
                {
                    "exact_snippets": "Candidate for locoregional radiotherapy",
                    "criterion": "locoregional radiotherapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer stage after definitive surgery",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "post-surgery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neoadjuvant chemotherapy was not administered: pathologic stage T3N0,T1-3 N1-2**",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant chemotherapy was not administered",
                    "criterion": "neoadjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologic stage T3N0",
                    "criterion": "pathologic stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T3N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologic stage ... T1-3 N1-2",
                    "criterion": "pathologic stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1-3 N1-2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "** patients with nodal micromets (N1mi) are eligible",
            "criterions": [
                {
                    "exact_snippets": "nodal micromets (N1mi)",
                    "criterion": "nodal micrometastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neoadjuvant chemotherapy was administered: clinical stage T3N0, T1-3, N1-2 and pathologic stage T0-3, N0-2†",
            "criterions": [
                {
                    "exact_snippets": "clinical stage T3N0, T1-3, N1-2",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T3N0",
                                "T1-3",
                                "N1-2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologic stage T0-3, N0-2",
                    "criterion": "pathologic stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T0-3",
                                "N0-2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are clinically N1-2 prior to chemotherapy should be confirmed histologically unless it is clear that they are node positive. Patients who are deemed node negative prior to chemotherapy but are node positive following chemotherapy are eligible. Patients who are node positive prior to chemotherapy and who have complete response in the lymph nodes are also eligible.",
            "criterions": [
                {
                    "exact_snippets": "clinically N1-2 prior to chemotherapy",
                    "criterion": "clinical nodal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "N1",
                                "N2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed histologically",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "node positive",
                    "criterion": "nodal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "node negative prior to chemotherapy",
                    "criterion": "nodal status prior to chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "node positive following chemotherapy",
                    "criterion": "nodal status following chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "node positive prior to chemotherapy",
                    "criterion": "nodal status prior to chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "complete response in the lymph nodes",
                    "criterion": "response in lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "complete"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. No evidence of metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "No evidence of metastatic disease.",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Age < 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age < 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Clinical stages T4 and/or N3.",
            "criterions": [
                {
                    "exact_snippets": "Clinical stages T4",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T4"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stages ... N3",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "N3"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Clinical lymphedema in the ipsilateral arm or breast/chest wall.",
            "criterions": [
                {
                    "exact_snippets": "Clinical lymphedema in the ipsilateral arm",
                    "criterion": "clinical lymphedema",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "ipsilateral arm"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical lymphedema in the ... breast/chest wall",
                    "criterion": "clinical lymphedema",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "breast",
                                "chest wall"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.)",
            "criterions": [
                {
                    "exact_snippets": "Synchronous or previous contralateral breast cancer",
                    "criterion": "contralateral breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous contralateral DCIS or LCIS not treated with radiation",
                    "criterion": "previous contralateral DCIS or LCIS",
                    "requirements": [
                        {
                            "requirement_type": "treatment with radiation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "History of non-breast malignancy within the last 5 years",
                    "criterion": "non-breast malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other than non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated in-situ carcinoma",
                    "criterion": "treated in-situ carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.)",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant endocrine therapy",
                    "criterion": "neoadjuvant endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Extended neoadjuvant endocrine therapy is not permitted",
                    "criterion": "extended neoadjuvant endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable",
                    "criterion": "endocrine therapy exposure duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Breast reconstruction.",
            "criterions": [
                {
                    "exact_snippets": "Breast reconstruction.",
                    "criterion": "breast reconstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Presence of known medical conditions that would preclude follow-up for 5 years.",
            "criterions": [
                {
                    "exact_snippets": "Presence of known medical conditions that would preclude follow-up for 5 years.",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "impact on follow-up",
                            "expected_value": "preclude follow-up for 5 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Previous radiotherapy to the ipsilateral breast or chest wall or serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Previous radiotherapy to the ipsilateral breast or chest wall",
                    "criterion": "previous radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "ipsilateral breast",
                                "chest wall"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy",
                    "criterion": "serious non-malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "scleroderma",
                                "severe lung disease",
                                "severe heart disease"
                            ]
                        },
                        {
                            "requirement_type": "impact on treatment",
                            "expected_value": "preclude radiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Known pregnancy or currently lactating.",
            "criterions": [
                {
                    "exact_snippets": "Known pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "currently lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Geographic inaccessibility for follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Geographic inaccessibility for follow-up",
                    "criterion": "geographic accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Inability to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Inability to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "4. Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with previous ipsilateral DCIS or LCIS not treated with radiation are eligible.)",
            "criterions": [
                {
                    "exact_snippets": "prior history, not including index cancer, of ipsilateral invasive breast cancer",
                    "criterion": "prior history of ipsilateral invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prior history, not including index cancer, of ipsilateral DCIS treated with radiation therapy",
                    "criterion": "prior history of ipsilateral DCIS treated with radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous ipsilateral DCIS or LCIS not treated with radiation",
                    "criterion": "previous ipsilateral DCIS or LCIS not treated with radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}