{
    "info": {
        "nct_id": "NCT05351294",
        "official_title": "Assessment of Early Radiation Oncology Involvement Alongside Standard Oncologic Care in the Management of Metastatic Malignancies",
        "inclusion_criteria": "The inclusion criteria for this study are as follows:\n\n1. Age ≥ 18 years\n2. Zubrod performance status 0-2\n3. Pathology-proven cancer, with primary site outside of the central nervous system\n4. Clinical (based on physical exam or imaging) or pathological diagnosis of metastatic disease, for which curative intent treatment is not feasible and treatment goals are palliative. Both patients with newly diagnosed metastatic disease, and those who have a metastatic relapse after prior curative-intent treatment for their malignancy, are eligible.\n5. Estimated life expectancy 6-24 months. Guidelines for estimating life expectancy will be based on best available evidence, based primarily on tumor type, systemic therapy used and its expected outcome, line of systemic therapy, and in some cases patients' initial response to systemic therapy, along with the enrolling medical oncologist's judgement.\n6. Either planned, or actively receiving, systemic therapy (chemotherapy, targeted/biologic therapy, immunotherapy, or hormonal therapy)\n7. Ability to understand and the willingness to sign a written informed consent document\n8. If a patient is actively participating in another clinical trial utilizing an investigation agent, they are still eligible for participation in this study unless radiation therapy is explicitly not allowed in that trial.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "The exclusion criteria for this study are as follows:\n\n1. Patients with metastatic solid tumors but life expectancy longer than 24 months will be excluded. This list includes (but is not limited to):\n\n   1. Castrate-sensitive prostate cancer (castrate-resistant prostate cancer are eligible)\n   2. Breast cancer responsive to hormonal therapy\n   3. Endometrial cancer responsive to hormonal therapy\n   4. Patients receiving first line systemic therapy, for whom median progression-free survival is greater than 6 months, and response to therapy has not been assessed yet.\n2. Patients considered metastatic only due to pleural or peritoneal metastases without metastases to any other organ are excluded since palliative radiation therapy is less commonly used in these cases.\n3. Patients with cancer considered incurable that is locally advanced but nonmetastatic.\n4. Patients with leukemia or primary central nervous system cancers will be excluded since these patients less commonly are treated with palliative radiation therapy. Patients with lymphoma and multiple myeloma are eligible if they meet the other eligibility criteria.\n5. Any patient for whom standard-of-care radiation oncology referral would be immediately indicated for palliative radiation therapy. The purpose of this is to ensure that patients in the control arm will not have a detriment in their care by not seeing a radiation oncologist at enrollment,\n6. In order to avoid bias from prior standard-of-care radiation oncology involvement, patients will also be excluded if they are undergoing active follow-up with a radiation oncologist after prior palliative radiation therapy.\n7. History of whole brain radiation therapy for brain metastases (patients who underwent one prior treatment with radiosurgery for brain metastases are eligible)\n8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, adrenal insufficiency, chronic liver disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n9. Pregnant or breastfeeding women; Subjects who are pregnant are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects.\n10. Cognitively impaired adults lacking decision-making capacity or unable to consent. -",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥ 18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Zubrod performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "Zubrod performance status 0-2",
                    "criterion": "Zubrod performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pathology-proven cancer, with primary site outside of the central nervous system",
            "criterions": [
                {
                    "exact_snippets": "Pathology-proven cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathology-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary site outside of the central nervous system",
                    "criterion": "primary cancer site",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "outside of the central nervous system"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Clinical (based on physical exam or imaging) or pathological diagnosis of metastatic disease, for which curative intent treatment is not feasible and treatment goals are palliative. Both patients with newly diagnosed metastatic disease, and those who have a metastatic relapse after prior curative-intent treatment for their malignancy, are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Clinical (based on physical exam or imaging) or pathological diagnosis of metastatic disease",
                    "criterion": "metastatic disease diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "clinical",
                                "pathological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for which curative intent treatment is not feasible",
                    "criterion": "curative intent treatment feasibility",
                    "requirements": [
                        {
                            "requirement_type": "feasibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment goals are palliative",
                    "criterion": "treatment goals",
                    "requirements": [
                        {
                            "requirement_type": "goal",
                            "expected_value": "palliative"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with newly diagnosed metastatic disease",
                    "criterion": "newly diagnosed metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic relapse after prior curative-intent treatment for their malignancy",
                    "criterion": "metastatic relapse",
                    "requirements": [
                        {
                            "requirement_type": "relapse status",
                            "expected_value": "after prior curative-intent treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Estimated life expectancy 6-24 months. Guidelines for estimating life expectancy will be based on best available evidence, based primarily on tumor type, systemic therapy used and its expected outcome, line of systemic therapy, and in some cases patients' initial response to systemic therapy, along with the enrolling medical oncologist's judgement.",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy 6-24 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "months"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor type",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "best available evidence"
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic therapy used",
                    "criterion": "systemic therapy used",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "best available evidence"
                        }
                    ]
                },
                {
                    "exact_snippets": "expected outcome",
                    "criterion": "expected outcome of systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "best available evidence"
                        }
                    ]
                },
                {
                    "exact_snippets": "line of systemic therapy",
                    "criterion": "line of systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "best available evidence"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients' initial response to systemic therapy",
                    "criterion": "initial response to systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "best available evidence"
                        }
                    ]
                },
                {
                    "exact_snippets": "enrolling medical oncologist's judgement",
                    "criterion": "medical oncologist's judgement",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "best available evidence"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Either planned, or actively receiving, systemic therapy (chemotherapy, targeted/biologic therapy, immunotherapy, or hormonal therapy)",
            "criterions": [
                {
                    "exact_snippets": "planned, or actively receiving, systemic therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "planned",
                                "actively receiving"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "planned",
                                "actively receiving"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted/biologic therapy",
                    "criterion": "targeted/biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "planned",
                                "actively receiving"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "planned",
                                "actively receiving"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "hormonal therapy",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "planned",
                                "actively receiving"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. If a patient is actively participating in another clinical trial utilizing an investigation agent, they are still eligible for participation in this study unless radiation therapy is explicitly not allowed in that trial.",
            "criterions": [
                {
                    "exact_snippets": "actively participating in another clinical trial utilizing an investigation agent",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless radiation therapy is explicitly not allowed in that trial",
                    "criterion": "radiation therapy allowance in other trial",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "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 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": "1. Patients with metastatic solid tumors but life expectancy longer than 24 months will be excluded. This list includes (but is not limited to):",
            "criterions": [
                {
                    "exact_snippets": "metastatic solid tumors",
                    "criterion": "metastatic solid tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy longer than 24 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Castrate-sensitive prostate cancer (castrate-resistant prostate cancer are eligible)",
            "criterions": [
                {
                    "exact_snippets": "Castrate-sensitive prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": "castrate-sensitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "castrate-resistant prostate cancer are eligible",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": "castrate-resistant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Breast cancer responsive to hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "Breast cancer responsive to hormonal therapy",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "responsiveness",
                            "expected_value": "hormonal therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Endometrial cancer responsive to hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "Endometrial cancer responsive to hormonal therapy",
                    "criterion": "endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "responsiveness",
                            "expected_value": "hormonal therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients receiving first line systemic therapy, for whom median progression-free survival is greater than 6 months, and response to therapy has not been assessed yet.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving first line systemic therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "line of therapy",
                            "expected_value": "first line"
                        }
                    ]
                },
                {
                    "exact_snippets": "median progression-free survival is greater than 6 months",
                    "criterion": "progression-free survival",
                    "requirements": [
                        {
                            "requirement_type": "median duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "response to therapy has not been assessed yet",
                    "criterion": "response to therapy",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients considered metastatic only due to pleural or peritoneal metastases without metastases to any other organ are excluded since palliative radiation therapy is less commonly used in these cases.",
            "criterions": [
                {
                    "exact_snippets": "metastatic only due to pleural or peritoneal metastases without metastases to any other organ",
                    "criterion": "metastatic status",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "pleural",
                                "peritoneal"
                            ]
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with cancer considered incurable that is locally advanced but nonmetastatic.",
            "criterions": [
                {
                    "exact_snippets": "Patients with cancer considered incurable",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": "incurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "nonmetastatic",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with leukemia or primary central nervous system cancers will be excluded since these patients less commonly are treated with palliative radiation therapy. Patients with lymphoma and multiple myeloma are eligible if they meet the other eligibility criteria.",
            "criterions": [
                {
                    "exact_snippets": "Patients with leukemia ... will be excluded",
                    "criterion": "leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "primary central nervous system cancers will be excluded",
                    "criterion": "primary central nervous system cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with lymphoma ... are eligible",
                    "criterion": "lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "multiple myeloma are eligible",
                    "criterion": "multiple myeloma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Any patient for whom standard-of-care radiation oncology referral would be immediately indicated for palliative radiation therapy. The purpose of this is to ensure that patients in the control arm will not have a detriment in their care by not seeing a radiation oncologist at enrollment,",
            "criterions": [
                {
                    "exact_snippets": "standard-of-care radiation oncology referral would be immediately indicated for palliative radiation therapy",
                    "criterion": "standard-of-care radiation oncology referral",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "immediate for palliative radiation therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. In order to avoid bias from prior standard-of-care radiation oncology involvement, patients will also be excluded if they are undergoing active follow-up with a radiation oncologist after prior palliative radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "undergoing active follow-up with a radiation oncologist after prior palliative radiation therapy",
                    "criterion": "active follow-up with a radiation oncologist",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of whole brain radiation therapy for brain metastases (patients who underwent one prior treatment with radiosurgery for brain metastases are eligible)",
            "criterions": [
                {
                    "exact_snippets": "History of whole brain radiation therapy for brain metastases",
                    "criterion": "whole brain radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who underwent one prior treatment with radiosurgery for brain metastases are eligible",
                    "criterion": "radiosurgery for brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, adrenal insufficiency, chronic liver disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... adrenal insufficiency",
                    "criterion": "adrenal insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... chronic liver disease",
                    "criterion": "chronic liver disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Pregnant or breastfeeding women; Subjects who are pregnant are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant ... Subjects who are pregnant are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Cognitively impaired adults lacking decision-making capacity or unable to consent. -",
            "criterions": [
                {
                    "exact_snippets": "Cognitively impaired adults",
                    "criterion": "cognitive impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lacking decision-making capacity",
                    "criterion": "decision-making capacity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to consent",
                    "criterion": "ability to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "The inclusion criteria for this study are as follows:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "The exclusion criteria for this study are as follows:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}