{
"info": {
"nct_id": "NCT04677673",
"official_title": "Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients",
"inclusion_criteria": "* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.\n* Clinical stage: cTNM: stage III\n* Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)\n* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.\n* Written informed consent\nHealthy volunteers allowed\nMust have minimum age of 76 Years",
"exclusion_criteria": "* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia\n* Distant metastases (including retroperitoneal lymph node)\n* Locally advanced inoperable disease (Clinical assessment)\n* Relapse of gastric cancer\n* Malignant secondary disease\n* Prior chemo or radiotherapy\n* Inclusion in another clinical trial\n* Known contraindications or hypersensitivity for planned chemotherapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Clinical stage: cTNM: stage III",
"criterions": [
{
"exact_snippets": "Clinical stage: cTNM: stage III",
"criterion": "clinical stage",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
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}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
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"criterion": "performance status",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 2,
"unit": "ECOG"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
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"operator": "<=",
"value": 2,
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{
"identified_line": {
"line": "* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.",
"criterions": [
{
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"criterion": "fitness for systemic chemotherapy",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Clinically fit for ... gastric cancer surgery",
"criterion": "fitness for gastric cancer surgery",
"requirement": {
"requirement_type": "fitness",
"expected_value": true
}
},
{
"exact_snippets": "adequate renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... hepatic ... function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... hematologic ... function",
"criterion": "hematologic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... pulmonary function",
"criterion": "pulmonary function",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Clinically fit for systemic chemotherapy",
"criterion": "fitness for systemic chemotherapy",
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"expected_value": true
}
},
{
"exact_snippets": "Clinically fit for ... gastric cancer surgery",
"criterion": "fitness for gastric cancer surgery",
"requirement": {
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"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "adequate renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... hepatic ... function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... hematologic ... function",
"criterion": "hematologic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "adequate ... pulmonary function",
"criterion": "pulmonary function",
"requirement": {
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"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Written informed consent",
"criterions": [
{
"exact_snippets": "Written informed consent",
"criterion": "informed consent",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"requirement": {
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"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 76 Years",
"criterions": [
{
"exact_snippets": "minimum age of 76 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 76,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "minimum age of 76 Years",
"criterion": "age",
"requirement": {
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"operator": ">=",
"value": 76,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Distant metastases (including retroperitoneal lymph node)",
"criterions": [
{
"exact_snippets": "Distant metastases",
"criterion": "distant metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "retroperitoneal lymph node",
"criterion": "retroperitoneal lymph node metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Distant metastases",
"criterion": "distant metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "retroperitoneal lymph node",
"criterion": "retroperitoneal lymph node metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Locally advanced inoperable disease (Clinical assessment)",
"criterions": [
{
"exact_snippets": "Locally advanced inoperable disease",
"criterion": "disease operability",
"requirement": {
"requirement_type": "operability",
"expected_value": "inoperable"
}
},
{
"exact_snippets": "Locally advanced inoperable disease",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Locally advanced inoperable disease",
"criterion": "disease operability",
"requirement": {
"requirement_type": "operability",
"expected_value": "inoperable"
}
},
{
"exact_snippets": "Locally advanced inoperable disease",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
}
]
}
},
{
"identified_line": {
"line": "* Relapse of gastric cancer",
"criterions": [
{
"exact_snippets": "Relapse of gastric cancer",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "relapse",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Relapse of gastric cancer",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "relapse",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Malignant secondary disease",
"criterions": [
{
"exact_snippets": "Malignant secondary disease",
"criterion": "malignant secondary disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Malignant secondary disease",
"criterion": "malignant secondary disease",
"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Prior chemo or radiotherapy",
"criterions": [
{
"exact_snippets": "Prior chemo or radiotherapy",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "types",
"expected_value": [
"chemo",
"radiotherapy"
]
}
}
]
},
"logical_structure": {
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"requirement": {
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"radiotherapy"
]
}
}
}
},
{
"identified_line": {
"line": "* Inclusion in another clinical trial",
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{
"exact_snippets": "Inclusion in another clinical trial",
"criterion": "inclusion in another clinical trial",
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"expected_value": false
}
}
]
},
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"expected_value": false
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.",
"criterions": [
{
"exact_snippets": "Histology confirmed",
"criterion": "histology confirmation",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "non-obstructive adenocarcinoma",
"criterion": "adenocarcinoma type",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "adenocarcinoma of the stomach or esophagogastric junction",
"criterion": "adenocarcinoma location",
"requirement": {
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"esophagogastric junction"
]
}
}
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"logical_structure": {
"and_criteria": [
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"and_criteria": [
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"expected_value": true
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{
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}
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"or_criteria": [
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"criterion": "adenocarcinoma location",
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}
},
{
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"requirement": {
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}
}
]
}
]
}
}
],
"failed_exclusion": [
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"identified_line": {
"line": "* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia",
"criterions": [
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"requirement": {
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"expected_value": false
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{
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"requirement": {
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"expected_value": false
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{
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"requirement": {
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}
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{
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"criterion": "clinically significant comorbidities",
"requirement": {
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"expected_value": false
}
},
{
"exact_snippets": "unable to undergo general anesthesia",
"criterion": "ability to undergo general anesthesia",
"requirement": {
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"expected_value": false
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}
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"logical_structure": {
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"criterion": "failed",
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"expected_value": "failed"
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},
{
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"criterions": [
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"exact_snippets": "Known contraindications ... for planned chemotherapy",
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"requirement": {
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}
},
{
"exact_snippets": "hypersensitivity for planned chemotherapy",
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}
]
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}
]
}
}
],
"failed_miscellaneous": []
}