{
"info": {
"nct_id": "NCT02080962",
"official_title": "Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial",
"inclusion_criteria": "* Cosmesis not important\n* Basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of any differentiation\n* Clinical stage I and II\n* Location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek\n* Patient with up to 3 injuries eligible for the study\n* Karnofsky Performance Status (KPS) ≥ 70%\n* Age > 18 years\n* Informed Consent signed by the patient consenting to undergo the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Indian Race\n* Prior treatment for their skin cancer\n* More than three synchronous lesions to treatment with RT\n* Basal syndrome, xeroderma, vitiligo and albinism\n* Immunosuppression\n* Prior burn at the tumor site\n* Tumor > 5 cm\n* Age <18 years\n* Carrier mental incapacity\n* People in a relationship of dependence as prisoners, soldiers, students, staff, etc..",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Cosmesis not important",
"criterions": [
{
"exact_snippets": "Cosmesis not important",
"criterion": "cosmesis",
"requirements": [
{
"requirement_type": "importance",
"expected_value": "not important"
}
]
}
]
},
{
"line": "* Basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of any differentiation",
"criterions": [
{
"exact_snippets": "Basal cell carcinoma (BCC)",
"criterion": "Basal cell carcinoma",
"requirements": [
{
"requirement_type": "differentiation",
"expected_value": "any"
}
]
},
{
"exact_snippets": "squamous cell carcinoma (SCC)",
"criterion": "squamous cell carcinoma",
"requirements": [
{
"requirement_type": "differentiation",
"expected_value": "any"
}
]
}
]
},
{
"line": "* Clinical stage I and II",
"criterions": [
{
"exact_snippets": "Clinical stage I and II",
"criterion": "clinical stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"I",
"II"
]
}
]
}
]
},
{
"line": "* Patient with up to 3 injuries eligible for the study",
"criterions": [
{
"exact_snippets": "up to 3 injuries",
"criterion": "number of injuries",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Karnofsky Performance Status (KPS) ≥ 70%",
"criterions": [
{
"exact_snippets": "Karnofsky Performance Status (KPS) ≥ 70%",
"criterion": "Karnofsky Performance Status (KPS)",
"requirements": [
{
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "%"
}
}
]
}
]
},
{
"line": "* Age > 18 years",
"criterions": [
{
"exact_snippets": "Age > 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Informed Consent signed by the patient consenting to undergo the study",
"criterions": [
{
"exact_snippets": "Informed Consent signed by the patient",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
}
]
}
]
},
{
"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": "* Indian Race",
"criterions": [
{
"exact_snippets": "Indian Race",
"criterion": "race",
"requirements": [
{
"requirement_type": "specificity",
"expected_value": "Indian"
}
]
}
]
},
{
"line": "* Prior treatment for their skin cancer",
"criterions": [
{
"exact_snippets": "Prior treatment for their skin cancer",
"criterion": "skin cancer treatment",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* More than three synchronous lesions to treatment with RT",
"criterions": [
{
"exact_snippets": "More than three synchronous lesions",
"criterion": "synchronous lesions",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Basal syndrome, xeroderma, vitiligo and albinism",
"criterions": [
{
"exact_snippets": "Basal syndrome",
"criterion": "Basal syndrome",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "xeroderma",
"criterion": "xeroderma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "vitiligo",
"criterion": "vitiligo",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "albinism",
"criterion": "albinism",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Immunosuppression",
"criterions": [
{
"exact_snippets": "Immunosuppression",
"criterion": "immunosuppression",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Prior burn at the tumor site",
"criterions": [
{
"exact_snippets": "Prior burn at the tumor site",
"criterion": "burn at the tumor site",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Tumor > 5 cm",
"criterions": [
{
"exact_snippets": "Tumor > 5 cm",
"criterion": "tumor size",
"requirements": [
{
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "cm"
}
}
]
}
]
},
{
"line": "* Age <18 years",
"criterions": [
{
"exact_snippets": "Age <18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Carrier mental incapacity",
"criterions": [
{
"exact_snippets": "Carrier mental incapacity",
"criterion": "mental capacity",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* People in a relationship of dependence as prisoners, soldiers, students, staff, etc..",
"criterions": [
{
"exact_snippets": "People in a relationship of dependence as prisoners",
"criterion": "relationship of dependence",
"requirements": [
{
"requirement_type": "examples",
"expected_value": [
"prisoners"
]
}
]
},
{
"exact_snippets": "People in a relationship of dependence as ... soldiers",
"criterion": "relationship of dependence",
"requirements": [
{
"requirement_type": "examples",
"expected_value": [
"soldiers"
]
}
]
},
{
"exact_snippets": "People in a relationship of dependence as ... students",
"criterion": "relationship of dependence",
"requirements": [
{
"requirement_type": "examples",
"expected_value": [
"students"
]
}
]
},
{
"exact_snippets": "People in a relationship of dependence as ... staff",
"criterion": "relationship of dependence",
"requirements": [
{
"requirement_type": "examples",
"expected_value": [
"staff"
]
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "* Location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek",
"criterions": [
{
"exact_snippets": "Location on the thorax",
"criterion": "location",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "thorax"
}
]
},
{
"exact_snippets": "Location on the abdomen",
"criterion": "location",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "abdomen"
}
]
},
{
"exact_snippets": "Location on the pelvis (except perineum)",
"criterion": "location",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "pelvis"
},
{
"requirement_type": "exclusion",
"expected_value": "perineum"
}
]
},
{
"exact_snippets": "Location on the arm",
"criterion": "location",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "arm"
}
]
},
{
"exact_snippets": "Location on the thigh",
"criterion": "location",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "thigh"
}
]
},
{
"exact_snippets": "Location on the cheek",
"criterion": "location",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "cheek"
}
]
}
]
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}