{
"info": {
"nct_id": "NCT00278148",
"official_title": "A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) With Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy With OSI-774 for Stage III Non-Small Cell Lung Cancer",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer\n\n * Surgically determined stage IIIA or IIIB disease\n * Histology from an involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs\n\n * Histological or cytological proof of mediastinal nodal involvement by mediastinoscopy, Chamberlain procedure, thoracoscopy, thoracotomy, or CT-guided biopsy is required except for cases of paralysis of left true vocal cord with separate left lung primary distinct from enlarged nodes > 1 cm in the anterior-posterior window seen on the CT scan\n* Patients with N3 or T4 status must be evaluated and deemed potentially resectable after induction chemotherapy and radiation therapy\n* Measurable and evaluable disease\n* No malignant pleural effusion except for effusion visible only on CT scan and deemed too small to tap\n* No pericardial effusion\n* No small or mixed small cell/non-small cell lung cancer\n* No massive lesions requiring radiation to the entire lung\n* No metastatic cancer to the lungs\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* WBC ≥ 3,000/mm^3\n* Platelet count > 100,000/mm^3\n* Serum creatinine ≤ 2.0 mg/dL\n* Alkaline phosphatase, AST, and ALT < 2 times upper limit of normal\n* Albumin > 3.0 g/dL\n* Serum bilirubin < 1.5 mg/dL\n* Adequate pulmonary function\n* No clinical evidence of another uncontrolled malignancy\n* No requirement for urgent therapy for severe local symptoms such as post-obstructive pneumonia\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy, radiation therapy, or immunotherapy for lung cancer\n* No prior surgery to treat the cancer"
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]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No prior surgery to treat the cancer",
"criterion": "prior surgery to treat the cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "* Patients with N3 or T4 status must be evaluated and deemed potentially resectable after induction chemotherapy and radiation therapy",
"criterions": [
{
"exact_snippets": "N3 or T4 status",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"N3",
"T4"
]
}
},
{
"exact_snippets": "must be evaluated and deemed potentially resectable",
"criterion": "resectability",
"requirement": {
"requirement_type": "evaluation",
"expected_value": "potentially resectable"
}
},
{
"exact_snippets": "after induction chemotherapy and radiation therapy",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "completion",
"expected_value": [
"induction chemotherapy",
"radiation therapy"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "N3 or T4 status",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "presence",
"expected_value": "N3"
}
},
{
"exact_snippets": "N3 or T4 status",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "presence",
"expected_value": "T4"
}
}
]
},
{
"exact_snippets": "must be evaluated and deemed potentially resectable",
"criterion": "resectability",
"requirement": {
"requirement_type": "evaluation",
"expected_value": "potentially resectable"
}
},
{
"exact_snippets": "after induction chemotherapy and radiation therapy",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "completion",
"expected_value": [
"induction chemotherapy",
"radiation therapy"
]
}
}
]
}
},
{
"identified_line": {
"line": "* No pericardial effusion",
"criterions": [
{
"exact_snippets": "No pericardial effusion",
"criterion": "pericardial effusion",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No pericardial effusion",
"criterion": "pericardial effusion",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* No metastatic cancer to the lungs",
"criterions": [
{
"exact_snippets": "No metastatic cancer to the lungs",
"criterion": "metastatic cancer to the lungs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No metastatic cancer to the lungs",
"criterion": "metastatic cancer to the lungs",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* WBC ≥ 3,000/mm^3",
"criterions": [
{
"exact_snippets": "WBC ≥ 3,000/mm^3",
"criterion": "WBC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3000,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "WBC \u001e 3,000/mm^3",
"criterion": "WBC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3000,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* No clinical evidence of another uncontrolled malignancy",
"criterions": [
{
"exact_snippets": "No clinical evidence of another uncontrolled malignancy",
"criterion": "uncontrolled malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "No clinical evidence of another uncontrolled malignancy",
"criterion": "uncontrolled malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
]
}