{
    "info": {
        "nct_id": "NCT00187031",
        "official_title": "A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor",
        "inclusion_criteria": "* Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment\n* Age< 21 years of age at the time of study entry\n* Adequate bone marrow function\n* Adequate liver function\n* Adequate renal function\n* Adequate performance status\nHealthy volunteers allowed\nMust have maximum age of 21 Years",
        "exclusion_criteria": "* Subject is pregnant\n* Subject is lactating\n* Renal tumors other than Wilms tumors",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment",
            "criterions": [
                {
                    "exact_snippets": "Favorable histology Wilms tumor",
                    "criterion": "Wilms tumor histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "favorable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Wilms tumor ... recurred or progressed after primary treatment",
                    "criterion": "Wilms tumor recurrence or progression",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recurred or progressed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Wilms tumor ... at least one standard salvage treatment regimen",
                    "criterion": "standard salvage treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anaplastic histology Wilms tumor",
                    "criterion": "Wilms tumor histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "anaplastic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age< 21 years of age at the time of study entry",
            "criterions": [
                {
                    "exact_snippets": "Age< 21 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver function",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate performance status",
            "criterions": [
                {
                    "exact_snippets": "Adequate performance status",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Subject is pregnant",
            "criterions": [
                {
                    "exact_snippets": "Subject is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is lactating",
            "criterions": [
                {
                    "exact_snippets": "Subject is lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal tumors other than Wilms tumors",
            "criterions": [
                {
                    "exact_snippets": "Renal tumors other than Wilms tumors",
                    "criterion": "renal tumors",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than Wilms tumors"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}