{
    "info": {
        "nct_id": "NCT01223248",
        "official_title": "A Phase III Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy in Patients With Metastatic Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma) The diagnosis can be done at MSKCC or at participating institutions.\n* Sites of metastatic disease to be treated on protocol are limited to bone, spine, soft tissue, and lymph nodes only.\n* Patients with American Joint Committee on Cancer (6th edition, 2002) Stage IV cancer with distant metastases\n* Age 18 years or older\n* Life expectancy >3 months\n* Maximum tumor dimension of ≤6 cm in lymph nodes, soft tissue, osseous metastases, or spinal metastases seen on imaging (computed tomography [CT], magnetic resonance imaging [MRI], or PET/CT) and considered amenable for RT.\n* If the lesion(s) to be treated are soft-tissue or lymph Nodes unidimensionally measurable disease is required. Bone & spine lesions are eligible even if considered non-measurable.\n* Measurable disease is defined as:\n* ≥ 10mm for soft-tissue lesions\n* ≥ 15mm on the short axis of lymph nodes\n* KPS ≥ 80\n* Patients must have normal bone marrow function as defined below:(within 2 months of registration) Hemoglobin ≥9.0 g/dl Absolute neutrophil count (ANC) ≥1,500/μl Platelets ≥100,000/μl\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior radiotherapy delivered to the target region\n* Disease to be treated on protocol is less than 2 mm from the spinal cord and therefore will not meet dose constraints*\n* Pregnancy or Breast-Feeding (Participants of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy).\n* Chemotherapy given on the day of the planned radiotherapy treatment\n* Lesions which comprise >70% of the width of weight bearing bones, such as the femur.\n* Existing cortical bone destruction, where orthopedic stabilization would be required.\n* Areas to be treated on protocol do not include metastases to liver, brain or lung.\n\n  * Note: Patients with eligible and ineligible lesions will be accrued to this protocol. Only target eligible lesions will be treated per protocol. Other eligible and ineligible lesions will be treated at the discretion of the treating physician.\"",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma) The diagnosis can be done at MSKCC or at participating institutions.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis of cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "including epithelial carcinoma, sarcoma, and melanoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "epithelial carcinoma",
                                "sarcoma",
                                "melanoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sites of metastatic disease to be treated on protocol are limited to bone, spine, soft tissue, and lymph nodes only.",
            "criterions": [
                {
                    "exact_snippets": "Sites of metastatic disease to be treated on protocol are limited to bone, spine, soft tissue, and lymph nodes only.",
                    "criterion": "sites of metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "bone",
                                "spine",
                                "soft tissue",
                                "lymph nodes"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with American Joint Committee on Cancer (6th edition, 2002) Stage IV cancer with distant metastases",
            "criterions": [
                {
                    "exact_snippets": "American Joint Committee on Cancer (6th edition, 2002) Stage IV cancer",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Stage IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "distant metastases",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 years or older",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy >3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy >3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Maximum tumor dimension of ≤6 cm in lymph nodes, soft tissue, osseous metastases, or spinal metastases seen on imaging (computed tomography [CT], magnetic resonance imaging [MRI], or PET/CT) and considered amenable for RT.",
            "criterions": [
                {
                    "exact_snippets": "Maximum tumor dimension of ≤6 cm",
                    "criterion": "tumor dimension",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph nodes, soft tissue, osseous metastases, or spinal metastases",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "lymph nodes",
                                "soft tissue",
                                "osseous metastases",
                                "spinal metastases"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "seen on imaging (computed tomography [CT], magnetic resonance imaging [MRI], or PET/CT)",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "computed tomography [CT]",
                                "magnetic resonance imaging [MRI]",
                                "PET/CT"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "considered amenable for RT",
                    "criterion": "amenability for RT",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If the lesion(s) to be treated are soft-tissue or lymph Nodes unidimensionally measurable disease is required. Bone & spine lesions are eligible even if considered non-measurable.",
            "criterions": [
                {
                    "exact_snippets": "lesion(s) to be treated are soft-tissue or lymph Nodes unidimensionally measurable disease is required",
                    "criterion": "soft-tissue or lymph nodes lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "unidimensionally measurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Bone & spine lesions are eligible even if considered non-measurable",
                    "criterion": "bone & spine lesions",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease is defined as:",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 10mm for soft-tissue lesions",
            "criterions": [
                {
                    "exact_snippets": "≥ 10mm for soft-tissue lesions",
                    "criterion": "soft-tissue lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 15mm on the short axis of lymph nodes",
            "criterions": [
                {
                    "exact_snippets": "≥ 15mm on the short axis of lymph nodes",
                    "criterion": "lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* KPS ≥ 80",
            "criterions": [
                {
                    "exact_snippets": "KPS ≥ 80",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have normal bone marrow function as defined below:(within 2 months of registration) Hemoglobin ≥9.0 g/dl Absolute neutrophil count (ANC) ≥1,500/μl Platelets ≥100,000/μl",
            "criterions": [
                {
                    "exact_snippets": "normal bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥9.0 g/dl",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥1,500/μl",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "μl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets ≥100,000/μl",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "μl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior radiotherapy delivered to the target region",
            "criterions": [
                {
                    "exact_snippets": "Prior radiotherapy delivered to the target region",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "delivery",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "target region",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease to be treated on protocol is less than 2 mm from the spinal cord and therefore will not meet dose constraints*",
            "criterions": [
                {
                    "exact_snippets": "Disease to be treated on protocol is less than 2 mm from the spinal cord",
                    "criterion": "distance from spinal cord",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or Breast-Feeding (Participants of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy).",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Breast-Feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants of child-bearing potential ... must consent to using effective contraception during therapy and for at least 3 months after completing therapy",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during therapy and for at least 3 months after completing therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy given on the day of the planned radiotherapy treatment",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy given on the day of the planned radiotherapy treatment",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "on the day of planned radiotherapy treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lesions which comprise >70% of the width of weight bearing bones, such as the femur.",
            "criterions": [
                {
                    "exact_snippets": "Lesions which comprise >70% of the width of weight bearing bones",
                    "criterion": "lesions in weight bearing bones",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 70,
                                "unit": "% of the width"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Existing cortical bone destruction, where orthopedic stabilization would be required.",
            "criterions": [
                {
                    "exact_snippets": "Existing cortical bone destruction",
                    "criterion": "cortical bone destruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "where orthopedic stabilization would be required",
                    "criterion": "orthopedic stabilization",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Areas to be treated on protocol do not include metastases to liver, brain or lung.",
            "criterions": [
                {
                    "exact_snippets": "Areas to be treated on protocol do not include metastases to liver",
                    "criterion": "metastases to liver",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Areas to be treated on protocol do not include metastases to ... brain",
                    "criterion": "metastases to brain",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Areas to be treated on protocol do not include metastases to ... lung",
                    "criterion": "metastases to lung",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: Patients with eligible and ineligible lesions will be accrued to this protocol. Only target eligible lesions will be treated per protocol. Other eligible and ineligible lesions will be treated at the discretion of the treating physician.\"",
            "criterions": [
                {
                    "exact_snippets": "Patients with eligible and ineligible lesions",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": [
                                "eligible",
                                "ineligible"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Only target eligible lesions will be treated per protocol",
                    "criterion": "target lesions",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "eligible"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}