{
    "info": {
        "nct_id": "NCT03612466",
        "official_title": "A Dose Finding Study of CycloSam® (153Sm-DOTMP) Combined With External Beam Radiotherapy to Treat High Risk Osteosarcoma and Other Solid Tumors Metastatic to Bone",
        "inclusion_criteria": "* Histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of osteosarcoma with either an unresectable primary tumor or metastases (including tumors with an intralesional resection).\n* Measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan.\n* Adequate renal function, defined as a measured creatinine clearance >70 ml/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR).\n* Adequate hematologic function, defined as a platelet count > 50,000 cells/mm3 and an absolute neutrophil count (ANC) > 500 cells/mm3\n* Life expectancy of at least 8 weeks.\n* Karnofsky performance status > 50%\n* Subject must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or better.\n* Patients must have previously received effective treatment for their underlying disease and have no potentially curative options available.\nHealthy volunteers allowed\nMust have minimum age of 15 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* Subject has received prior radiotherapy to all known areas of current active disease or has a known contraindication to receiving radiotherapy.\n* Subject is pregnant or breastfeeding.\n* Patient is sexually active and does not agree to use accepted, effective forms of contraception.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of osteosarcoma with either an unresectable primary tumor or metastases (including tumors with an intralesional resection).",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of a solid tumor metastatic to bone",
                    "criterion": "solid tumor metastatic to bone",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed diagnosis of osteosarcoma",
                    "criterion": "osteosarcoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "osteosarcoma with either an unresectable primary tumor",
                    "criterion": "unresectable primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "osteosarcoma with ... metastases",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors with an intralesional resection",
                    "criterion": "intralesional resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease on anatomic imaging",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "avid for phosphonate compounds",
                    "criterion": "avidity for phosphonate compounds",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive 99mTc diphosphonate bone scan",
                    "criterion": "99mTc diphosphonate bone scan",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function, defined as a measured creatinine clearance >70 ml/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR).",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function, defined as a measured creatinine clearance >70 ml/min/1.73 m2",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">",
                                "value": 70,
                                "unit": "ml/min/1.73 m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate renal function, defined as ... normal radioisotope glomerular filtration rate (GFR)",
                    "criterion": "radioisotope glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic function, defined as a platelet count > 50,000 cells/mm3 and an absolute neutrophil count (ANC) > 500 cells/mm3",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic function, defined as a platelet count > 50,000 cells/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50000,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function, defined as ... an absolute neutrophil count (ANC) > 500 cells/mm3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 500,
                                "unit": "cells/mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 8 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 8 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status > 50%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status > 50%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or better.",
            "criterions": [
                {
                    "exact_snippets": "adequately recovered from the effects of any prior chemotherapy",
                    "criterion": "recovery from prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Toxicities from previous therapies must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or better",
                    "criterion": "toxicities from previous therapies",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "CTCAE 4.0 grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have previously received effective treatment for their underlying disease and have no potentially curative options available.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have previously received effective treatment for their underlying disease",
                    "criterion": "previous treatment for underlying disease",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have no potentially curative options available",
                    "criterion": "curative options",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "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 15 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 15 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Subject has received prior radiotherapy to all known areas of current active disease or has a known contraindication to receiving radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Subject has received prior radiotherapy to all known areas of current active disease",
                    "criterion": "prior radiotherapy to all known areas of current active disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has a known contraindication to receiving radiotherapy",
                    "criterion": "contraindication to receiving radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject is pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Subject is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is sexually active and does not agree to use accepted, effective forms of contraception.",
            "criterions": [
                {
                    "exact_snippets": "Patient is sexually active",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "does not agree to use accepted, effective forms of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}