{
"info": {
"nct_id": "NCT01105182",
"official_title": "A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors",
"inclusion_criteria": "* adult (> 18 years) male or female patient\n* patient has biopsy-proven NSCLC or lung metastasis\n* patient has been rejected for surgery and has been considered unfit for radiation therapy\n* each 6 cm or smaller in greatest diameter of tumor, by CT scan\n* tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart\n* tumors are accessible by percutaneous route\n* patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5\n* patient has signed written informed consent prior to any study specific procedures.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* patient is considered at high-risk for RF ablation due to major co-morbid medical conditions\n* patient has more than 3 tumors / lung\n* patient has at least one tumor > 6 cm in greatest diameter\n* tumor is associated with atelectasis or obstructive pneumonitis\n* patient has renal failure requiring hemodialysis or peritoneal dialysis\n* patient has active clinically serious infection\n* patient has history of organ allograft\n* patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results\n* patient is pregnant or breast-feeding\n* patient has ECOG performance status > 2\n* patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* adult (> 18 years) male or female patient",
"criterions": [
{
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"criterion": "age",
"requirement": {
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"operator": ">",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "male or female",
"criterion": "gender",
"requirement": {
"requirement_type": "allowed_values",
"expected_value": [
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"female"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
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"value": 18,
"unit": "years"
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}
},
{
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"female"
]
}
}
]
}
},
{
"identified_line": {
"line": "* patient has biopsy-proven NSCLC or lung metastasis",
"criterions": [
{
"exact_snippets": "biopsy-proven NSCLC",
"criterion": "NSCLC",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "biopsy-proven ... lung metastasis",
"criterion": "lung metastasis",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
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"criterion": "NSCLC",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "biopsy-proven ... lung metastasis",
"criterion": "lung metastasis",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* patient has been rejected for surgery and has been considered unfit for radiation therapy",
"criterions": [
{
"exact_snippets": "patient has been rejected for surgery",
"criterion": "surgery eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
},
{
"exact_snippets": "considered unfit for radiation therapy",
"criterion": "radiation therapy fitness",
"requirement": {
"requirement_type": "fitness",
"expected_value": false
}
}
]
},
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"exact_snippets": "patient has been rejected for surgery",
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"expected_value": false
}
},
{
"exact_snippets": "considered unfit for radiation therapy",
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* each 6 cm or smaller in greatest diameter of tumor, by CT scan",
"criterions": [
{
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"criterion": "tumor size",
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"operator": "<=",
"value": 6,
"unit": "cm"
}
}
}
]
},
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"operator": "<=",
"value": 6,
"unit": "cm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart",
"criterions": [
{
"exact_snippets": "tumors are located at least 1 cm from trachea",
"criterion": "tumor location relative to trachea",
"requirement": {
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"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... main bronchi",
"criterion": "tumor location relative to main bronchi",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... esophagus",
"criterion": "tumor location relative to esophagus",
"requirement": {
"requirement_type": "distance",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... aorta",
"criterion": "tumor location relative to aorta",
"requirement": {
"requirement_type": "distance",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... aortic arch branches",
"criterion": "tumor location relative to aortic arch branches",
"requirement": {
"requirement_type": "distance",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... pulmonary artery",
"criterion": "tumor location relative to pulmonary artery",
"requirement": {
"requirement_type": "distance",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... heart",
"criterion": "tumor location relative to heart",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
}
]
},
"logical_structure": {
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"criterion": "tumor location relative to trachea",
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"expected_value": {
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"value": 1,
"unit": "cm"
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}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... main bronchi",
"criterion": "tumor location relative to main bronchi",
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"operator": ">=",
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"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... esophagus",
"criterion": "tumor location relative to esophagus",
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"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
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"criterion": "tumor location relative to aorta",
"requirement": {
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"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... aortic arch branches",
"criterion": "tumor location relative to aortic arch branches",
"requirement": {
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"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... pulmonary artery",
"criterion": "tumor location relative to pulmonary artery",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "cm"
}
}
},
{
"exact_snippets": "tumors are located at least 1 cm from ... heart",
"criterion": "tumor location relative to heart",
"requirement": {
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"operator": ">=",
"value": 1,
"unit": "cm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* tumors are accessible by percutaneous route",
"criterions": [
{
"exact_snippets": "tumors are accessible by percutaneous route",
"criterion": "tumor accessibility",
"requirement": {
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"expected_value": "percutaneous route"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "tumors are accessible by percutaneous route",
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"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "* patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2",
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{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2",
"criterion": "ECOG performance status",
"requirement": {
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]
}
}
]
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}
}
]
}
},
{
"identified_line": {
"line": "* patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5",
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{
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"operator": ">",
"value": 100,
"unit": "x 109 /L"
}
}
},
{
"exact_snippets": "international normalized ratio ≤ 1.5",
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"value": 1.5,
"unit": "N/A"
}
}
}
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"unit": "x 109 /L"
}
}
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{
"exact_snippets": "international normalized ratio ≤ 1.5",
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"value": 1.5,
"unit": "N/A"
}
}
}
]
}
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{
"identified_line": {
"line": "* patient has signed written informed consent prior to any study specific procedures.",
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{
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}
}
]
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}
}
]
}
},
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"identified_line": {
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}
}
]
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}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
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{
"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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}
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]
},
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}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
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{
"exact_snippets": "maximum age of 80 Years",
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}
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},
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"exact_snippets": "maximum age of 80 Years",
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}
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}
}
],
"exclusion_lines": [
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{
"exact_snippets": "high-risk for RF ablation",
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{
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"and_criteria": [
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}
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]
}
},
{
"identified_line": {
"line": "* patient has more than 3 tumors / lung",
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{
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"operator": ">",
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"unit": "N/A"
}
}
},
{
"exact_snippets": "lung",
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}
]
},
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"unit": "N/A"
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}
},
{
"identified_line": {
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{
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{
"exact_snippets": "tumor is associated with atelectasis",
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"expected_value": "tumor"
}
},
{
"exact_snippets": "tumor is associated with ... obstructive pneumonitis",
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}
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}
]
}
},
{
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"line": "* patient has renal failure requiring hemodialysis or peritoneal dialysis",
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{
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"expected_value": true
}
},
{
"exact_snippets": "requiring hemodialysis",
"criterion": "hemodialysis",
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}
},
{
"exact_snippets": "requiring ... peritoneal dialysis",
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]
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}
},
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}
},
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]
}
},
{
"identified_line": {
"line": "* patient has history of organ allograft",
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{
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}
}
]
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}
}
]
}
},
{
"identified_line": {
"line": "* patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results",
"criterions": [
{
"exact_snippets": "patient has history of substance abuse",
"criterion": "substance abuse history",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results",
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}
}
]
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}
},
{
"exact_snippets": "any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results",
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}
}
]
}
},
{
"identified_line": {
"line": "* patient is pregnant or breast-feeding",
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"exact_snippets": "patient is pregnant",
"criterion": "pregnancy",
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"expected_value": true
}
},
{
"exact_snippets": "breast-feeding",
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}
}
]
},
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"exact_snippets": "patient is pregnant",
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}
},
{
"exact_snippets": "breast-feeding",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* patient has ECOG performance status > 2",
"criterions": [
{
"exact_snippets": "ECOG performance status > 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "performance status",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "ECOG performance status > 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "performance status",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "N/A"
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.",
"criterions": [
{
"exact_snippets": "platelet count ≤ 100 x 109 /L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 100,
"unit": "x 10^9 /L"
}
}
},
{
"exact_snippets": "international normalized ratio > 1.5",
"criterion": "international normalized ratio",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "platelet count \u0010 100 x 109 /L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 100,
"unit": "x 10^9 /L"
}
}
},
{
"exact_snippets": "international normalized ratio > 1.5",
"criterion": "international normalized ratio",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1.5,
"unit": "N/A"
}
}
}
]
}
}
],
"failed_miscellaneous": []
}