{
    "info": {
        "nct_id": "NCT04574960",
        "official_title": "Neoadjuvant Chemotherapy in Upper Tract Urothelial Cancer: A Multicentre, Feasibility Pilot Trial",
        "inclusion_criteria": "* Newly diagnosed radiographically visible (CT or MRI) cT1-4 N0 M0 with positive selective urinary cytology, positive bladder urinary cytology, or endoscopic biopsy for high grade urothelial cell carcinoma\n* Age ≥18 years of age\n* Eastern Cooperative Oncology Group (ECOG) score 0-1\n* Medically appropriate candidate for radical nephroureterectomy or ureterectomy as per participating site attending urologic oncologist\n* Medically appropriate candidate for cisplatin-based chemotherapy as per participating site attending medical oncologist\n* Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L, ALT and AST < 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 60 mL/min\n\nPatients who are randomized to the adjuvant chemotherapy will be reassessed for suitability to receive adjuvant chemotherapy after definitive surgery (nephroureterectomy or ureterectomy) based on the following criteria:\n\n* pT2-4 N0-3 M0 or pT any N1-3 M0 with predominant urothelial component\n* ECOG score 0-2\n* Medically appropriate candidate for platin-based chemotherapy as per participating site attending medical oncologist\n* Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L, ALT and AST < 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 30 mL/min\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Metastatic disease\n* Radiographically visible nodal disease\n* Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable)\n* Solitary kidney\n* Other cancer diagnosis or systemic chemotherapy use within 2 years of study enrollment (prior bladder cancer and intravesical therapy allowed)\n* Concomitant diseases that are a formal exclusion to cisplatin chemotherapy (deafness, ≥ grade II neuropathy, serious active infection)\n* Concomitant use of any other investigational drugs\n* Pregnancy or breast feeding (you must remain on contraception, not father a child or donate sperm while receiving gemcitabine/cisplatin and for 6 months following the last dose)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Newly diagnosed radiographically visible (CT or MRI) cT1-4 N0 M0 with positive selective urinary cytology, positive bladder urinary cytology, or endoscopic biopsy for high grade urothelial cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed radiographically visible (CT or MRI) cT1-4 N0 M0",
                    "criterion": "cT1-4 N0 M0",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive selective urinary cytology",
                    "criterion": "selective urinary cytology",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive bladder urinary cytology",
                    "criterion": "bladder urinary cytology",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "endoscopic biopsy for high grade urothelial cell carcinoma",
                    "criterion": "endoscopic biopsy for high grade urothelial cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) score 0-1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score 0-1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically appropriate candidate for radical nephroureterectomy or ureterectomy as per participating site attending urologic oncologist",
            "criterions": [
                {
                    "exact_snippets": "Medically appropriate candidate for radical nephroureterectomy or ureterectomy",
                    "criterion": "candidate for radical nephroureterectomy or ureterectomy",
                    "requirements": [
                        {
                            "requirement_type": "medical appropriateness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically appropriate candidate for cisplatin-based chemotherapy as per participating site attending medical oncologist",
            "criterions": [
                {
                    "exact_snippets": "Medically appropriate candidate for cisplatin-based chemotherapy",
                    "criterion": "cisplatin-based chemotherapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as per participating site attending medical oncologist",
                    "criterion": "approval by attending medical oncologist",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L, ALT and AST < 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count ≥ 1500/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ≥ 100,00/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥ 90 g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST < 2.5 x upper limit of normal",
                    "criterion": "ALT and AST",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "electrolytes (Na, K, Mg, Ca): within normal limits",
                    "criterion": "electrolytes (Na, K, Mg, Ca)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "GFR ≥ 60 mL/min",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients who are randomized to the adjuvant chemotherapy will be reassessed for suitability to receive adjuvant chemotherapy after definitive surgery (nephroureterectomy or ureterectomy) based on the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "suitability to receive adjuvant chemotherapy",
                    "criterion": "suitability for adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "suitable"
                        }
                    ]
                },
                {
                    "exact_snippets": "definitive surgery (nephroureterectomy or ureterectomy)",
                    "criterion": "definitive surgery type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "nephroureterectomy",
                                "ureterectomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* pT2-4 N0-3 M0 or pT any N1-3 M0 with predominant urothelial component",
            "criterions": [
                {
                    "exact_snippets": "pT2-4 N0-3 M0",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "pT2",
                                "pT3",
                                "pT4"
                            ]
                        },
                        {
                            "requirement_type": "node involvement",
                            "expected_value": [
                                "N0",
                                "N1",
                                "N2",
                                "N3"
                            ]
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": "M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "pT any N1-3 M0",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "node involvement",
                            "expected_value": [
                                "N1",
                                "N2",
                                "N3"
                            ]
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": "M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "predominant urothelial component",
                    "criterion": "tumor histology",
                    "requirements": [
                        {
                            "requirement_type": "component",
                            "expected_value": "urothelial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG score 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG score 0-2",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically appropriate candidate for platin-based chemotherapy as per participating site attending medical oncologist",
            "criterions": [
                {
                    "exact_snippets": "Medically appropriate candidate for platin-based chemotherapy",
                    "criterion": "platin-based chemotherapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ system function defined as follows: absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,00/mm3, hemoglobin ≥ 90 g/L, ALT and AST < 2.5 x upper limit of normal, electrolytes (Na, K, Mg, Ca): within normal limits, GFR ≥ 30 mL/min",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count ≥ 1500/mm3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ≥ 100,00/mm3",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥ 90 g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST < 2.5 x upper limit of normal",
                    "criterion": "ALT and AST",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "electrolytes (Na, K, Mg, Ca): within normal limits",
                    "criterion": "electrolytes (Na, K, Mg, Ca)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal limits"
                        }
                    ]
                },
                {
                    "exact_snippets": "GFR ≥ 30 mL/min",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiographically visible nodal disease",
            "criterions": [
                {
                    "exact_snippets": "Radiographically visible nodal disease",
                    "criterion": "nodal disease",
                    "requirements": [
                        {
                            "requirement_type": "visibility",
                            "expected_value": "radiographically visible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent muscle-invasive bladder cancer (non-muscle invasive bladder cancer is acceptable)",
            "criterions": [
                {
                    "exact_snippets": "Concurrent muscle-invasive bladder cancer",
                    "criterion": "muscle-invasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-muscle invasive bladder cancer is acceptable",
                    "criterion": "non-muscle invasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Solitary kidney",
            "criterions": [
                {
                    "exact_snippets": "Solitary kidney",
                    "criterion": "solitary kidney",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other cancer diagnosis or systemic chemotherapy use within 2 years of study enrollment (prior bladder cancer and intravesical therapy allowed)",
            "criterions": [
                {
                    "exact_snippets": "Other cancer diagnosis",
                    "criterion": "other cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic chemotherapy use within 2 years of study enrollment",
                    "criterion": "systemic chemotherapy use",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant diseases that are a formal exclusion to cisplatin chemotherapy (deafness, ≥ grade II neuropathy, serious active infection)",
            "criterions": [
                {
                    "exact_snippets": "Concomitant diseases that are a formal exclusion to cisplatin chemotherapy (deafness",
                    "criterion": "deafness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant diseases that are a formal exclusion to cisplatin chemotherapy ... ≥ grade II neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant diseases that are a formal exclusion to cisplatin chemotherapy ... serious active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant use of any other investigational drugs",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of any other investigational drugs",
                    "criterion": "use of investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "concomitant use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breast feeding (you must remain on contraception, not father a child or donate sperm while receiving gemcitabine/cisplatin and for 6 months following the last dose)",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "remain on contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not father a child",
                    "criterion": "fathering a child",
                    "requirements": [
                        {
                            "requirement_type": "action",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "donate sperm",
                    "criterion": "sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "action",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "while receiving gemcitabine/cisplatin and for 6 months following the last dose",
                    "criterion": "duration of contraception and sperm donation restrictions",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while receiving gemcitabine/cisplatin and for 6 months following the last dose"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}