{
"info": {
"nct_id": "NCT06427460",
"official_title": "Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk",
"inclusion_criteria": "* Aged 18-75 years.\n* Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.\n* Oligometastasis in the case of metastatic tumor\n* the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm\n* ECOG of 0 to 1 point\n* No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10^9/L, neutrophil count ≥2.0×10^9, hemoglobin level ≥100g/L, platelet count ≥100×10^9/L, ALT and AST level < 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio <2)\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* History of radiotherapy for the lesion\n* History of tumor within 5 years\n* ECOG ≥2 points\n* Significant abnormality in blood routine test, liver and kidney function test and coagulation test\n* Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor\n* Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor\n* Infections required antibiotics\n* Heart or respiratory insufficiency\n* Pregnant or breastfeeding women",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Aged 18-75 years.",
"criterions": [
{
"exact_snippets": "Aged 18-75 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Aged 18-75 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.",
"criterions": [
{
"exact_snippets": "Pathologically confirmed lung ... malignant tumor.",
"criterion": "lung malignant tumor",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "Pathologically confirmed ... liver ... malignant tumor.",
"criterion": "liver malignant tumor",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "Pathologically confirmed ... pancreas ... malignant tumor.",
"criterion": "pancreas malignant tumor",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "Pathologically confirmed ... retroperitoneal malignant tumor.",
"criterion": "retroperitoneal malignant tumor",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pathologically confirmed lung ... malignant tumor.",
"criterion": "lung malignant tumor",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "Pathologically confirmed ... liver ... malignant tumor.",
"criterion": "liver malignant tumor",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "Pathologically confirmed ... pancreas ... malignant tumor.",
"criterion": "pancreas malignant tumor",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "Pathologically confirmed ... retroperitoneal malignant tumor.",
"criterion": "retroperitoneal malignant tumor",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
}
]
}
},
{
"identified_line": {
"line": "* Oligometastasis in the case of metastatic tumor",
"criterions": [
{
"exact_snippets": "Oligometastasis in the case of metastatic tumor",
"criterion": "oligometastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Oligometastasis in the case of metastatic tumor",
"criterion": "metastatic tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Oligometastasis in the case of metastatic tumor",
"criterion": "oligometastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm",
"criterions": [
{
"exact_snippets": "shortest diameter ≥2cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "shortest diameter",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "cm"
}
}
},
{
"exact_snippets": "distance from the tumor to the organs at risk less than 5mm",
"criterion": "distance from tumor to organs at risk",
"requirement": {
"requirement_type": "distance",
"expected_value": {
"operator": "<",
"value": 5,
"unit": "mm"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "shortest diameter ≥2cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "shortest diameter",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "cm"
}
}
},
{
"exact_snippets": "distance from the tumor to the organs at risk less than 5mm",
"criterion": "distance from tumor to organs at risk",
"requirement": {
"requirement_type": "distance",
"expected_value": {
"operator": "<",
"value": 5,
"unit": "mm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* ECOG of 0 to 1 point",
"criterions": [
{
"exact_snippets": "ECOG of 0 to 1 point",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "point"
},
{
"operator": "<=",
"value": 1,
"unit": "point"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG of 0 to 1 point",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "point"
},
{
"operator": "<=",
"value": 1,
"unit": "point"
}
]
}
}
}
]
}
},
{
"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": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* History of radiotherapy for the lesion",
"criterions": [
{
"exact_snippets": "History of radiotherapy for the lesion",
"criterion": "radiotherapy history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "History of radiotherapy for the lesion",
"criterion": "radiotherapy history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* History of tumor within 5 years",
"criterions": [
{
"exact_snippets": "History of tumor within 5 years",
"criterion": "tumor history",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "History of tumor within 5 years",
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"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
}
}
},
{
"identified_line": {
"line": "* ECOG ≥2 points",
"criterions": [
{
"exact_snippets": "ECOG ≥2 points",
"criterion": "ECOG",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "points"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG ≥2 points",
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"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "points"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Significant abnormality in blood routine test, liver and kidney function test and coagulation test",
"criterions": [
{
"exact_snippets": "Significant abnormality in blood routine test",
"criterion": "blood routine test",
"requirement": {
"requirement_type": "abnormality",
"expected_value": "significant"
}
},
{
"exact_snippets": "Significant abnormality in ... liver ... function test",
"criterion": "liver function test",
"requirement": {
"requirement_type": "abnormality",
"expected_value": "significant"
}
},
{
"exact_snippets": "Significant abnormality in ... kidney function test",
"criterion": "kidney function test",
"requirement": {
"requirement_type": "abnormality",
"expected_value": "significant"
}
},
{
"exact_snippets": "Significant abnormality in ... coagulation test",
"criterion": "coagulation test",
"requirement": {
"requirement_type": "abnormality",
"expected_value": "significant"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Significant abnormality in blood routine test",
"criterion": "blood routine test",
"requirement": {
"requirement_type": "abnormality",
"expected_value": "significant"
}
},
{
"exact_snippets": "Significant abnormality in ... liver ... function test",
"criterion": "liver function test",
"requirement": {
"requirement_type": "abnormality",
"expected_value": "significant"
}
}
]
},
{
"exact_snippets": "Significant abnormality in ... kidney function test",
"criterion": "kidney function test",
"requirement": {
"requirement_type": "abnormality",
"expected_value": "significant"
}
}
]
},
{
"exact_snippets": "Significant abnormality in ... coagulation test",
"criterion": "coagulation test",
"requirement": {
"requirement_type": "abnormality",
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}
}
]
}
},
{
"identified_line": {
"line": "* Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor",
"criterions": [
{
"exact_snippets": "Active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pancreas or retroperitoneal tumor",
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"requirement": {
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]
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"exact_snippets": "Active inflammatory bowel disease",
"criterion": "inflammatory bowel disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pancreas or retroperitoneal tumor",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
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"pancreas",
"retroperitoneal"
]
}
}
]
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor",
"criterions": [
{
"exact_snippets": "Gastrointestinal bleeding or perforation within 6 months",
"criterion": "gastrointestinal bleeding or perforation",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "pancreas or retroperitoneal tumor",
"criterion": "tumor location",
"requirement": {
"requirement_type": "location",
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"pancreas",
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]
}
}
]
},
"logical_structure": {
"condition": {
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{
"exact_snippets": "Gastrointestinal bleeding or perforation within 6 months",
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"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
},
{
"exact_snippets": "pancreas or retroperitoneal tumor",
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"requirement": {
"requirement_type": "location",
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"pancreas",
"retroperitoneal"
]
}
}
]
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Infections required antibiotics",
"criterions": [
{
"exact_snippets": "Infections required antibiotics",
"criterion": "infections",
"requirement": {
"requirement_type": "treatment",
"expected_value": "antibiotics"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Infections required antibiotics",
"criterion": "infections",
"requirement": {
"requirement_type": "treatment",
"expected_value": "antibiotics"
}
}
]
}
},
{
"identified_line": {
"line": "* Heart or respiratory insufficiency",
"criterions": [
{
"exact_snippets": "Heart ... insufficiency",
"criterion": "heart insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "respiratory insufficiency",
"criterion": "respiratory insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Heart ... insufficiency",
"criterion": "heart insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "respiratory insufficiency",
"criterion": "respiratory insufficiency",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10^9/L, neutrophil count ≥2.0×10^9, hemoglobin level ≥100g/L, platelet count ≥100×10^9/L, ALT and AST level < 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio <2)",
"criterions": [
{
"exact_snippets": "No abnormality in blood routine test",
"criterion": "blood routine test",
"requirement": {
"requirement_type": "abnormality",
"expected_value": false
}
},
{
"exact_snippets": "White blood cell count ≥4.0×10^9/L",
"criterion": "white blood cell count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 4.0,
"unit": "×10^9/L"
}
}
},
{
"exact_snippets": "neutrophil count ≥2.0×10^9",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2.0,
"unit": "×10^9"
}
}
},
{
"exact_snippets": "hemoglobin level ≥100g/L",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "g/L"
}
}
},
{
"exact_snippets": "platelet count ≥100×10^9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "×10^9/L"
}
}
},
{
"exact_snippets": "ALT and AST level < 2.5 times the upper limit of normal",
"criterion": "ALT and AST level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "times the upper limit of normal"
}
}
},
{
"exact_snippets": "total bilirubin and creatinine level within the normal",
"criterion": "total bilirubin and creatinine level",
"requirement": {
"requirement_type": "range",
"expected_value": "within the normal"
}
},
{
"exact_snippets": "international normalized ratio <2",
"criterion": "international normalized ratio",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": ""
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No abnormality in blood routine test",
"criterion": "blood routine test",
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"requirement_type": "abnormality",
"expected_value": false
}
},
{
"exact_snippets": "White blood cell count ≥4.0×10^9/L",
"criterion": "white blood cell count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 4,
"unit": "×10^9/L"
}
}
}
]
},
{
"exact_snippets": "neutrophil count ≥2.0×10^9",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "×10^9"
}
}
}
]
},
{
"exact_snippets": "hemoglobin level ≥100g/L",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "g/L"
}
}
}
]
},
{
"exact_snippets": "platelet count ≥100×10^9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "×10^9/L"
}
}
}
]
},
{
"exact_snippets": "ALT and AST level < 2.5 times the upper limit of normal",
"criterion": "ALT and AST level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2.5,
"unit": "times the upper limit of normal"
}
}
}
]
},
{
"exact_snippets": "total bilirubin and creatinine level within the normal",
"criterion": "total bilirubin and creatinine level",
"requirement": {
"requirement_type": "range",
"expected_value": "within the normal"
}
}
]
},
{
"exact_snippets": "international normalized ratio <2",
"criterion": "international normalized ratio",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": ""
}
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Pregnant or breastfeeding women",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}