{
"info": {
"nct_id": "NCT00946673",
"official_title": "A Phase I Trial of Vorinostat Concurrent With Stereotactic Radiotherapy in Treatment of Brain Metastases From Non-Small Cell Lung Cancer",
"inclusion_criteria": "* All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.\n* Adequate organ function (section 3.1.10).\n* ECOG performance status 0-2.\n* Life expectancy of >=12 weeks.\n* Systemic chemotherapy washout period >=7 days.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "Patients who have previously been treated with whole brain irradiation, pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* All patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation.",
"criterions": [
{
"exact_snippets": "age 18 years and older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "histologically proven non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "histologically proven"
}
]
},
{
"exact_snippets": "1-4 brain metastases",
"criterion": "brain metastases",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 4,
"unit": "N/A"
}
]
}
}
]
},
{
"exact_snippets": "each measuring less than 2 cm",
"criterion": "brain metastases size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": "<",
"value": 2,
"unit": "cm"
}
}
]
},
{
"exact_snippets": "Prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"surgery",
"radiation"
]
},
{
"requirement_type": "condition",
"expected_value": "target metastatic lesion(s) has not been treated with previous radiation"
}
]
}
]
},
{
"line": "* Adequate organ function (section 3.1.10).",
"criterions": [
{
"exact_snippets": "Adequate organ function",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* ECOG performance status 0-2.",
"criterions": [
{
"exact_snippets": "ECOG performance status 0-2",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Life expectancy of >=12 weeks.",
"criterions": [
{
"exact_snippets": "Life expectancy of >=12 weeks.",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* Systemic chemotherapy washout period >=7 days.",
"criterions": [
{
"exact_snippets": "Systemic chemotherapy washout period >=7 days.",
"criterion": "systemic chemotherapy washout period",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "Patients who have previously been treated with whole brain irradiation, pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent.",
"criterions": [
{
"exact_snippets": "previously been treated with whole brain irradiation",
"criterion": "whole brain irradiation treatment",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "pediatric patients (age <18)",
"criterion": "age",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "pregnant women",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "unable to give informed consent",
"criterion": "ability to give informed consent",
"requirements": [
{
"requirement_type": "capability",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}