{
"info": {
"nct_id": "NCT01645748",
"official_title": "Multicenter Phase II Study of Weekly Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Squamous Cell Cancer of the Head and Neck",
"inclusion_criteria": "* locally advanced stage III or IV squamous cell carcinoma of the larynx, oropharynx, or hypopharynx\n* ≥18 years old\n* absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL\n* serum bilirubin <2.0 mg/dL\n* creatinine <1.5 mg/dL\n* serum transaminase levels less than twice the upper limit of normal\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* received previous chemotherapy\n* another malignancy\n* current or history of distant metastasis\n* history of clinically significant cardiac disease within 6 months\n* active serious infection\n* nasopharyngeal carcinoma\n* psychiatric illness that would preclude obtaining informed consent",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* locally advanced stage III or IV squamous cell carcinoma of the larynx, oropharynx, or hypopharynx",
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{
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"requirement": {
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},
{
"exact_snippets": "larynx",
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"requirement": {
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"expected_value": "larynx"
}
},
{
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"requirement": {
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}
},
{
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"requirement": {
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}
}
]
},
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{
"and_criteria": [
{
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{
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]
}
},
{
"identified_line": {
"line": "* ≥18 years old",
"criterions": [
{
"exact_snippets": "≥18 years old",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
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"unit": "years"
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{
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"criterion": "absolute neutrophil count",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "µL"
}
}
},
{
"exact_snippets": "platelets ≥100,000/µL",
"criterion": "platelets",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "µL"
}
}
}
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"criterion": "absolute neutrophil count",
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"value": 1500,
"unit": "µL"
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},
{
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"unit": "µL"
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"line": "* serum bilirubin <2.0 mg/dL",
"criterions": [
{
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"criterion": "serum bilirubin",
"requirement": {
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"value": 2.0,
"unit": "mg/dL"
}
}
}
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},
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"criterion": "serum bilirubin",
"requirement": {
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"value": 2.0,
"unit": "mg/dL"
}
}
}
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},
{
"identified_line": {
"line": "* creatinine <1.5 mg/dL",
"criterions": [
{
"exact_snippets": "creatinine <1.5 mg/dL",
"criterion": "creatinine",
"requirement": {
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"value": 1.5,
"unit": "mg/dL"
}
}
}
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},
"logical_structure": {
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"exact_snippets": "creatinine <1.5 mg/dL",
"criterion": "creatinine",
"requirement": {
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"value": 1.5,
"unit": "mg/dL"
}
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}
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},
{
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"criterions": [
{
"exact_snippets": "serum transaminase levels less than twice the upper limit of normal",
"criterion": "serum transaminase levels",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "times the upper limit of normal"
}
}
}
]
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"logical_structure": {
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"exact_snippets": "serum transaminase levels less than twice the upper limit of normal",
"criterion": "serum transaminase levels",
"requirement": {
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"expected_value": {
"operator": "<",
"value": 2,
"unit": "times the upper limit of normal"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
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"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
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"unit": "Years"
}
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"logical_structure": {
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"value": 18,
"unit": "Years"
}
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]
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"exclusion_lines": [
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"line": "* received previous chemotherapy",
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{
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"criterion": "previous chemotherapy",
"requirement": {
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"expected_value": true
}
}
]
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}
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"criterion": "malignancy",
"requirement": {
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"expected_value": true
}
}
]
},
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"criterion": "distant metastasis",
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"expected_value": true
}
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{
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"criterion": "distant metastasis",
"requirement": {
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"value": 6,
"unit": "months"
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"expected_value": true
}
}
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}
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"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}