{
"info": {
"nct_id": "NCT05059782",
"official_title": "Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer",
"inclusion_criteria": "1. Age ≥18;\n2. Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)\n3. Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions ≤3;\n4. No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency\n5. Cooperative Oncology Group-Status (ECOG Status) score 0-2;\n6. Expected survival ≥3 months;\n7. Feasible abdomen and pelvic cavity MRI/CT;\n8. Good compliance, signed informed consent voluntarily.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Previous radiotherapy at the target lesion site;\n2. History of active inflammatory bowel disease or severe stomach and duodenal ulcers;\n3. Human immunodeficiency virus (HIV) infected persons;\n4. active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit);\n5. suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication:\n6. patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin);\n7. neurological or mental disorders that affect cognitive ability;\n8. Patients whose lesions have been evaluated by the investigator and cannot be treated with external irradiation or endovascular radiation therapy;\n9. those who cannot follow up regularly as prescribed by the doctor;\n10. Other reasons not suitable for participating in this study as judged by the researcher.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Age ≥18;",
"criterions": [
{
"exact_snippets": "Age ≥18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age ≥18",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Evidence of histological diagnosis of ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)",
"criterions": [
{
"exact_snippets": "Evidence of histological diagnosis of ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histological"
}
},
{
"exact_snippets": "Evidence of histological diagnosis of ... fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histological"
}
},
{
"exact_snippets": "Evidence of histological diagnosis of ... primary peritoneal cancer",
"criterion": "primary peritoneal cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histological"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Evidence of histological diagnosis of ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histological"
}
},
{
"exact_snippets": "Evidence of histological diagnosis of ... fallopian tube cancer",
"criterion": "fallopian tube cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histological"
}
},
{
"exact_snippets": "Evidence of histological diagnosis of ... primary peritoneal cancer",
"criterion": "primary peritoneal cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "histological"
}
}
]
}
},
{
"identified_line": {
"line": "3. Pathology or imaging suggested recurrence, with measurable lesions, and the number of lesions ≤3;",
"criterions": [
{
"exact_snippets": "Pathology or imaging suggested recurrence",
"criterion": "recurrence",
"requirement": {
"requirement_type": "suggested by",
"expected_value": [
"pathology",
"imaging"
]
}
},
{
"exact_snippets": "measurable lesions",
"criterion": "lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
},
{
"exact_snippets": "number of lesions ≤3",
"criterion": "number of lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Pathology or imaging suggested recurrence",
"criterion": "recurrence",
"requirement": {
"requirement_type": "suggested by",
"expected_value": [
"pathology",
"imaging"
]
}
},
{
"exact_snippets": "measurable lesions",
"criterion": "lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "number of lesions ≤3",
"criterion": "number of lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "N/A"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "4. No serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney and immune deficiency",
"criterions": [
{
"exact_snippets": "No serious hematopoietic dysfunction",
"criterion": "hematopoietic dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "not serious"
}
},
{
"exact_snippets": "abnormal heart",
"criterion": "heart",
"requirement": {
"requirement_type": "normality",
"expected_value": "normal"
}
},
{
"exact_snippets": "abnormal ... lung",
"criterion": "lung",
"requirement": {
"requirement_type": "normality",
"expected_value": "normal"
}
},
{
"exact_snippets": "abnormal ... liver",
"criterion": "liver",
"requirement": {
"requirement_type": "normality",
"expected_value": "normal"
}
},
{
"exact_snippets": "abnormal ... kidney",
"criterion": "kidney",
"requirement": {
"requirement_type": "normality",
"expected_value": "normal"
}
},
{
"exact_snippets": "abnormal ... immune deficiency",
"criterion": "immune system",
"requirement": {
"requirement_type": "deficiency",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No serious hematopoietic dysfunction",
"criterion": "hematopoietic dysfunction",
"requirement": {
"requirement_type": "severity",
"expected_value": "not serious"
}
},
{
"exact_snippets": "abnormal heart",
"criterion": "heart",
"requirement": {
"requirement_type": "normality",
"expected_value": "normal"
}
},
{
"exact_snippets": "abnormal ... lung",
"criterion": "lung",
"requirement": {
"requirement_type": "normality",
"expected_value": "normal"
}
},
{
"exact_snippets": "abnormal ... liver",
"criterion": "liver",
"requirement": {
"requirement_type": "normality",
"expected_value": "normal"
}
},
{
"exact_snippets": "abnormal ... kidney",
"criterion": "kidney",
"requirement": {
"requirement_type": "normality",
"expected_value": "normal"
}
}
]
},
{
"exact_snippets": "abnormal ... immune deficiency",
"criterion": "immune system",
"requirement": {
"requirement_type": "deficiency",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Previous radiotherapy at the target lesion site;",
"criterions": [
{
"exact_snippets": "Previous radiotherapy at the target lesion site",
"criterion": "radiotherapy at the target lesion site",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Previous radiotherapy at the target lesion site",
"criterion": "radiotherapy at the target lesion site",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "2. History of active inflammatory bowel disease or severe stomach and duodenal ulcers;",
"criterions": [
{
"exact_snippets": "History of active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "History of active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "severe stomach and duodenal ulcers",
"criterion": "stomach and duodenal ulcers",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "History of active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
{
"exact_snippets": "severe stomach and duodenal ulcers",
"criterion": "stomach and duodenal ulcers",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
}
]
}
},
{
"identified_line": {
"line": "3. Human immunodeficiency virus (HIV) infected persons;",
"criterions": [
{
"exact_snippets": "Human immunodeficiency virus (HIV) infected persons",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Human immunodeficiency virus (HIV) infected persons",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "4. active hepatitis b (HBVDNA quantitative test results exceed the lower limit), or HCV infection (HCVRNA quantitative test results exceed the lower limit);",
"criterions": [
{
"exact_snippets": "active hepatitis b (HBVDNA quantitative test results exceed the lower limit)",
"criterion": "hepatitis B",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "active hepatitis b (HBVDNA quantitative test results exceed the lower limit)",
"criterion": "hepatitis B",
"requirement": {
"requirement_type": "HBVDNA quantitative test results",
"expected_value": {
"operator": ">",
"value": 0,
"unit": "lower limit"
}
}
},
{
"exact_snippets": "HCV infection (HCVRNA quantitative test results exceed the lower limit)",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HCV infection (HCVRNA quantitative test results exceed the lower limit)",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "HCVRNA quantitative test results",
"expected_value": {
"operator": ">",
"value": 0,
"unit": "lower limit"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "active hepatitis b (HBVDNA quantitative test results exceed the lower limit)",
"criterion": "hepatitis B",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "active hepatitis b (HBVDNA quantitative test results exceed the lower limit)",
"criterion": "hepatitis B",
"requirement": {
"requirement_type": "HBVDNA quantitative test results",
"expected_value": {
"operator": ">",
"value": 0,
"unit": "lower limit"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "HCV infection (HCVRNA quantitative test results exceed the lower limit)",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "HCV infection (HCVRNA quantitative test results exceed the lower limit)",
"criterion": "HCV infection",
"requirement": {
"requirement_type": "HCVRNA quantitative test results",
"expected_value": {
"operator": ">",
"value": 0,
"unit": "lower limit"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "5. suffering from serious underlying diseases, including but not limited to active infections requiring systemic medication:",
"criterions": [
{
"exact_snippets": "suffering from serious underlying diseases",
"criterion": "serious underlying diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "active infections requiring systemic medication",
"criterion": "active infections",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic medication"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "suffering from serious underlying diseases",
"criterion": "serious underlying diseases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "active infections requiring systemic medication",
"criterion": "active infections",
"requirement": {
"requirement_type": "treatment",
"expected_value": "systemic medication"
}
}
]
}
},
{
"identified_line": {
"line": "6. patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin);",
"criterions": [
{
"exact_snippets": "history of other malignant tumors",
"criterion": "history of other malignant tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "except cured basal cell carcinoma of the skin",
"criterion": "cured basal cell carcinoma of the skin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "history of other malignant tumors",
"criterion": "history of other malignant tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "except cured basal cell carcinoma of the skin",
"criterion": "cured basal cell carcinoma of the skin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "7. neurological or mental disorders that affect cognitive ability;",
"criterions": [
{
"exact_snippets": "neurological or mental disorders that affect cognitive ability",
"criterion": "neurological or mental disorders",
"requirement": {
"requirement_type": "effect on cognitive ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "neurological or mental disorders that affect cognitive ability",
"criterion": "neurological or mental disorders",
"requirement": {
"requirement_type": "effect on cognitive ability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "8. Patients whose lesions have been evaluated by the investigator and cannot be treated with external irradiation or endovascular radiation therapy;",
"criterions": [
{
"exact_snippets": "lesions have been evaluated by the investigator",
"criterion": "lesion evaluation",
"requirement": {
"requirement_type": "evaluation",
"expected_value": "by the investigator"
}
},
{
"exact_snippets": "lesions ... cannot be treated with external irradiation",
"criterion": "lesion treatment with external irradiation",
"requirement": {
"requirement_type": "treatability",
"expected_value": false
}
},
{
"exact_snippets": "lesions ... cannot be treated with ... endovascular radiation therapy",
"criterion": "lesion treatment with endovascular radiation therapy",
"requirement": {
"requirement_type": "treatability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "lesions have been evaluated by the investigator",
"criterion": "lesion evaluation",
"requirement": {
"requirement_type": "evaluation",
"expected_value": "by the investigator"
}
},
{
"and_criteria": [
{
"exact_snippets": "lesions ... cannot be treated with external irradiation",
"criterion": "lesion treatment with external irradiation",
"requirement": {
"requirement_type": "treatability",
"expected_value": false
}
},
{
"exact_snippets": "lesions ... cannot be treated with ... endovascular radiation therapy",
"criterion": "lesion treatment with endovascular radiation therapy",
"requirement": {
"requirement_type": "treatability",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "9. those who cannot follow up regularly as prescribed by the doctor;",
"criterions": [
{
"exact_snippets": "cannot follow up regularly as prescribed by the doctor",
"criterion": "ability to follow up regularly",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "cannot follow up regularly as prescribed by the doctor",
"criterion": "ability to follow up regularly",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "10. Other reasons not suitable for participating in this study as judged by the researcher.",
"criterions": [
{
"exact_snippets": "Other reasons not suitable for participating in this study as judged by the researcher.",
"criterion": "suitability for participation",
"requirement": {
"requirement_type": "judgment",
"expected_value": "as judged by the researcher"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Other reasons not suitable for participating in this study as judged by the researcher.",
"criterion": "suitability for participation",
"requirement": {
"requirement_type": "judgment",
"expected_value": "as judged by the researcher"
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "5. Cooperative Oncology Group-Status (ECOG Status) score 0-2;",
"criterions": [
{
"exact_snippets": "Cooperative Oncology Group-Status (ECOG Status) score 0-2",
"criterion": "ECOG Status",
"requirement": {
"requirement_type": "score",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "6. Expected survival ≥3 months;",
"criterions": [
{
"exact_snippets": "Expected survival ≥3 months",
"criterion": "expected survival",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "7. Feasible abdomen and pelvic cavity MRI/CT;",
"criterions": [
{
"exact_snippets": "Feasible abdomen and pelvic cavity MRI/CT",
"criterion": "abdomen and pelvic cavity MRI/CT",
"requirement": {
"requirement_type": "feasibility",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "8. Good compliance, signed informed consent voluntarily.",
"criterions": [
{
"exact_snippets": "Good compliance",
"criterion": "compliance",
"requirement": {
"requirement_type": "quality",
"expected_value": "good"
}
},
{
"exact_snippets": "signed informed consent voluntarily",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
},
{
"exact_snippets": "signed informed consent voluntarily",
"criterion": "informed consent",
"requirement": {
"requirement_type": "voluntary",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}