{
"info": {
"nct_id": "NCT02454673",
"official_title": "Approximation to the Therapeutic Individualization in Patients With Locally Advanced Gastric and Gastroesophageal Cancer Through Modelling and Generation of Predictive Gene Signatures",
"inclusion_criteria": "* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer\n* Age ≥18 years old\n* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1\n* Body mass index ≥ 18\n* No prior chemotherapy or chemoradiotherapy\n* TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)\n* No evidence of metastasis (M0)\n* Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
"exclusion_criteria": "* Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated\n* Patients with evidence of severe or uncontrolled systemic disease\n* Medically unfit for chemotherapy",
"miscellaneous_criteria": ""
},
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"line": "* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer",
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},
{
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}
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{
"exact_snippets": "Age ≥18 years old",
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"value": 18,
"unit": "years"
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"unit": "years"
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"line": "* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1",
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"criterion": "Performance Status",
"requirement": {
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}
},
{
"exact_snippets": "Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1",
"criterion": "Performance Status",
"requirement": {
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"expected_value": {
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"operator": ">=",
"value": 0,
"unit": "N/A"
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"value": 1,
"unit": "N/A"
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}
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},
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"value": 0,
"unit": "N/A"
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"value": 1,
"unit": "N/A"
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}
}
}
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}
},
{
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"line": "* Body mass index ≥ 18",
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"exact_snippets": "Body mass index ≥ 18",
"criterion": "body mass index",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "N/A"
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"unit": "N/A"
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"criterion": "prior chemotherapy",
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"expected_value": false
}
},
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}
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{
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"expected_value": {
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"operator": ">=",
"value": 3,
"unit": "T"
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{
"operator": "<=",
"value": 4,
"unit": "T"
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"criterion": "regional lymph nodes",
"requirement": {
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"expected_value": "positive"
}
},
{
"exact_snippets": "endoscopic ultrasound or computed tomography (CT)",
"criterion": "diagnostic method",
"requirement": {
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"computed tomography"
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}
}
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"and_criteria": [
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"exact_snippets": "TNM stage of T3-T4",
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"value": 3,
"unit": "T"
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"unit": "T"
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"criterion": "diagnostic method",
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"computed tomography"
]
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"criterion": "diagnostic method",
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"computed tomography"
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{
"identified_line": {
"line": "* No evidence of metastasis (M0)",
"criterions": [
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"exact_snippets": "No evidence of metastasis (M0)",
"criterion": "metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"requirement": {
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"expected_value": false
}
}
]
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},
{
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"line": "* Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)",
"criterions": [
{
"exact_snippets": "Adequate hematological ... functions",
"criterion": "hematological functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... liver ... functions",
"criterion": "liver functions",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... renal functions",
"criterion": "renal functions",
"requirement": {
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"expected_value": true
}
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{
"exact_snippets": "ALT ... ≤2.5 UNL",
"criterion": "ALT",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "UNL"
}
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"exact_snippets": "AST≤2.5 UNL",
"criterion": "AST",
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"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "UNL"
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"exact_snippets": "total bilirubin ≤1.5 UNL",
"criterion": "total bilirubin",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "UNL"
}
}
},
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"exact_snippets": "serum creatinine ≤1.5 UNL",
"criterion": "serum creatinine",
"requirement": {
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"expected_value": {
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"value": 1.5,
"unit": "UNL"
}
}
}
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"and_criteria": [
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"exact_snippets": "total bilirubin ≤1.5 UNL",
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"unit": "UNL"
}
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"criterion": "serum creatinine",
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"value": 1.5,
"unit": "UNL"
}
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},
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"identified_line": {
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"exact_snippets": "maximum age of 85 Years",
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"expected_value": {
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"value": 85,
"unit": "Years"
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"unit": "Years"
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"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}