{
"info": {
"nct_id": "NCT00359866",
"official_title": "Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients",
"inclusion_criteria": "* Age >= 18\n* Karnofsky Performance Status of >= 60\n* FIGO Stage I -IIB\n* Pathologic confirmation of cervical cancer\n* Status post hysterectomy\n* Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Age < 18\n* Karnofsky Performance Status < 60\n* Radiographic or pathologic evidence of distant metastatic disease\n* Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy irradiation for acute hemostasis",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Age >= 18",
"criterions": [
{
"exact_snippets": "Age >= 18",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Karnofsky Performance Status of >= 60",
"criterions": [
{
"exact_snippets": "Karnofsky Performance Status of >= 60",
"criterion": "Karnofsky Performance Status",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* FIGO Stage I -IIB",
"criterions": [
{
"exact_snippets": "FIGO Stage I -IIB",
"criterion": "FIGO stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Pathologic confirmation of cervical cancer",
"criterions": [
{
"exact_snippets": "Pathologic confirmation of cervical cancer",
"criterion": "cervical cancer",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "pathologic"
}
]
}
]
},
{
"line": "* Status post hysterectomy",
"criterions": [
{
"exact_snippets": "Status post hysterectomy",
"criterion": "hysterectomy",
"requirements": [
{
"requirement_type": "status",
"expected_value": "post"
}
]
}
]
},
{
"line": "* Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases",
"criterions": [
{
"exact_snippets": "local or regional metastases",
"criterion": "metastases location",
"requirements": [
{
"requirement_type": "location",
"expected_value": [
"local",
"regional"
]
}
]
},
{
"exact_snippets": "not those with distant metastases",
"criterion": "metastases location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "not distant"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "expected_value",
"expected_value": "female"
}
]
}
]
},
{
"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": "* Age < 18",
"criterions": [
{
"exact_snippets": "Age < 18",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Karnofsky Performance Status < 60",
"criterions": [
{
"exact_snippets": "Karnofsky Performance Status < 60",
"criterion": "Karnofsky Performance Status",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 60,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Radiographic or pathologic evidence of distant metastatic disease",
"criterions": [
{
"exact_snippets": "Radiographic or pathologic evidence of distant metastatic disease",
"criterion": "distant metastatic disease",
"requirements": [
{
"requirement_type": "evidence",
"expected_value": [
"radiographic",
"pathologic"
]
}
]
}
]
},
{
"line": "* Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy irradiation for acute hemostasis",
"criterions": [
{
"exact_snippets": "Prior pelvic radiation therapy",
"criterion": "prior pelvic radiation therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "other than trans-vaginal ring brachytherapy irradiation for acute hemostasis",
"criterion": "trans-vaginal ring brachytherapy irradiation for acute hemostasis",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}