{
    "info": {
        "nct_id": "NCT04070976",
        "official_title": "Phase II Randomized Controlled Trial of Concomitant Chemoradiotherapy With Standard Fractionation Compared to Hypofractionated Concomitant Chemoradiotherapy Followed by Brachytherapy, for Clinical Stage III Cervical Cancer Patients",
        "inclusion_criteria": "* Women over 18 years old\n* Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages\n* Histology: squamous, adenosquamous or adenocarcinoma\n* No previous treatment\n* No distance metastases, discard by Positron Emission Tomography (PET)/CT\n* Functional State ECOG (Eastern Cooperative Oncology Group) 0-2\n* Complete Blood count obtained at least 14 days before admission to the study with adequate bone marrow function defined as:\n* Absolute neutrophil count ≥ 1,500 cell/mm3\n* Platelets ≥ 100,000 cell/mm3\n* Hemoglobin ≥ 10.0 g/dl\n* Leukocyte count ≥ 4000 cell/mm3\n* Adequate Renal Function defined as:\n* Serum Creatinine ≤ 1.5 mg/dl within 14 days before admission to the study\n* Patients with HIV infection (human immunodeficiency virus) must have a CD4 cell count ≥ 350 cells / mm3 measured within 14 days prior to study entry (no HIV test is required)\n* The patient must understand the protocol and provide the specific informed consent of the study before admission\n* Negative pregnancy test\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies\n* Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)\n* Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years\n* Severe active or non-controlled co-morbidities, defined as:\n* Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.\n* Transmural myocardial infarction in the last 6 months.\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the beginning of the study.\n* Chronic obstructive pulmonary disease exacerbation or another respiratory disease that requires hospitalization or that contraindicates the trial therapy at the time of admission.\n* Crohn's disease or ulcerative colitis.\n* Prior allergic reaction to cisplatin or other drugs based on platinum.\n* Other factors that contraindicate experimental therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women over 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "over 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages",
            "criterions": [
                {
                    "exact_snippets": "Cervical Cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "IIIA, IIIB y IIIC1 FIGO´s clinical stages",
                    "criterion": "FIGO clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIA",
                                "IIIB",
                                "IIIC1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histology: squamous, adenosquamous or adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histology: squamous, adenosquamous or adenocarcinoma",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "squamous",
                                "adenosquamous",
                                "adenocarcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous treatment",
            "criterions": [
                {
                    "exact_snippets": "No previous treatment",
                    "criterion": "previous treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No distance metastases, discard by Positron Emission Tomography (PET)/CT",
            "criterions": [
                {
                    "exact_snippets": "No distance metastases",
                    "criterion": "distance metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "discard by Positron Emission Tomography (PET)/CT",
                    "criterion": "Positron Emission Tomography (PET)/CT",
                    "requirements": [
                        {
                            "requirement_type": "method of assessment",
                            "expected_value": "PET/CT"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Functional State ECOG (Eastern Cooperative Oncology Group) 0-2",
            "criterions": [
                {
                    "exact_snippets": "Functional State ECOG (Eastern Cooperative Oncology Group) 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Complete Blood count obtained at least 14 days before admission to the study with adequate bone marrow function defined as:",
            "criterions": [
                {
                    "exact_snippets": "Complete Blood count obtained at least 14 days before admission to the study",
                    "criterion": "complete blood count",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at least 14 days before admission to the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500 cell/mm3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500 cell/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "cell/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000 cell/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000 cell/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "cell/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 10.0 g/dl",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 10.0 g/dl",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocyte count ≥ 4000 cell/mm3",
            "criterions": [
                {
                    "exact_snippets": "Leukocyte count ≥ 4000 cell/mm3",
                    "criterion": "leukocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4000,
                                "unit": "cell/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate Renal Function defined as:",
            "criterions": [
                {
                    "exact_snippets": "Adequate Renal Function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum Creatinine ≤ 1.5 mg/dl within 14 days before admission to the study",
            "criterions": [
                {
                    "exact_snippets": "Serum Creatinine ≤ 1.5 mg/dl",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days before admission to the study",
                    "criterion": "timeframe for serum creatinine measurement",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 14 days before admission to the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with HIV infection (human immunodeficiency virus) must have a CD4 cell count ≥ 350 cells / mm3 measured within 14 days prior to study entry (no HIV test is required)",
            "criterions": [
                {
                    "exact_snippets": "Patients with HIV infection (human immunodeficiency virus)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a CD4 cell count ≥ 350 cells / mm3",
                    "criterion": "CD4 cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 350,
                                "unit": "cells / mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured within 14 days prior to study entry",
                    "criterion": "CD4 cell count measurement timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days prior to study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must understand the protocol and provide the specific informed consent of the study before admission",
            "criterions": [
                {
                    "exact_snippets": "The patient must understand the protocol",
                    "criterion": "understanding of the protocol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provide the specific informed consent of the study",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies",
            "criterions": [
                {
                    "exact_snippets": "chemotherapeutic ... treatment for female reproductive tract pathologies",
                    "criterion": "chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical ... treatment for female reproductive tract pathologies",
                    "criterion": "surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy treatment for female reproductive tract pathologies",
                    "criterion": "radiotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female reproductive tract pathologies",
                    "criterion": "female reproductive tract pathologies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)",
            "criterions": [
                {
                    "exact_snippets": "Previous invasive neoplasia (except non-melanoma skin cancer)",
                    "criterion": "previous invasive neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "complete remission of the disease of 3 years minimum",
                    "criterion": "remission duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years",
            "criterions": [
                {
                    "exact_snippets": "Previous systemic chemotherapy for current cervical cancer",
                    "criterion": "previous systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "cancer type",
                            "expected_value": "current cervical cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior chemotherapy for a different cancer is accepted",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "cancer type",
                            "expected_value": "different cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "as long as they have been at least 3 years",
                    "criterion": "time since prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe active or non-controlled co-morbidities, defined as:",
            "criterions": [
                {
                    "exact_snippets": "Severe active or non-controlled co-morbidities",
                    "criterion": "co-morbidities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required hospitalization in the last 6 months",
                    "criterion": "hospitalization",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "last 6 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Transmural myocardial infarction in the last 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Transmural myocardial infarction in the last 6 months.",
                    "criterion": "transmural myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute bacterial or fungal infection requiring intravenous antibiotics at the beginning of the study.",
            "criterions": [
                {
                    "exact_snippets": "Acute bacterial or fungal infection",
                    "criterion": "infection type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "bacterial",
                                "fungal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring intravenous antibiotics",
                    "criterion": "antibiotic treatment",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "intravenous"
                        }
                    ]
                },
                {
                    "exact_snippets": "at the beginning of the study",
                    "criterion": "timing of infection",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "beginning of the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic obstructive pulmonary disease exacerbation or another respiratory disease that requires hospitalization or that contraindicates the trial therapy at the time of admission.",
            "criterions": [
                {
                    "exact_snippets": "Chronic obstructive pulmonary disease exacerbation",
                    "criterion": "chronic obstructive pulmonary disease exacerbation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "another respiratory disease that requires hospitalization",
                    "criterion": "respiratory disease requiring hospitalization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "respiratory disease ... that contraindicates the trial therapy",
                    "criterion": "respiratory disease contraindicating trial therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Crohn's disease or ulcerative colitis.",
            "criterions": [
                {
                    "exact_snippets": "Crohn's disease",
                    "criterion": "Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcerative colitis",
                    "criterion": "ulcerative colitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allergic reaction to cisplatin or other drugs based on platinum.",
            "criterions": [
                {
                    "exact_snippets": "Prior allergic reaction to cisplatin",
                    "criterion": "allergic reaction to cisplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic reaction to ... other drugs based on platinum",
                    "criterion": "allergic reaction to platinum-based drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other factors that contraindicate experimental therapy.",
            "criterions": [
                {
                    "exact_snippets": "factors that contraindicate experimental therapy",
                    "criterion": "contraindicating factors for experimental therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}