{
"info": {
"nct_id": "NCT00984282",
"official_title": "A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer",
"inclusion_criteria": "* Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)\n* Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features\n* Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors] should be used as a basis for the assessment of disease progression)\n* RAI (radioactive iodine) refractory\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)\n* Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents\n* Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)",
"criterions": [
{
"exact_snippets": "Locally advanced or metastatic differentiated thyroid cancer",
"criterion": "differentiated thyroid cancer",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"metastatic"
]
}
]
},
{
"exact_snippets": "papillary",
"criterion": "thyroid cancer subtype",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "papillary"
}
]
},
{
"exact_snippets": "follicular",
"criterion": "thyroid cancer subtype",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "follicular"
}
]
},
{
"exact_snippets": "Hurthle cell",
"criterion": "thyroid cancer subtype",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "Hurthle cell"
}
]
}
]
},
{
"line": "* Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features",
"criterions": [
{
"exact_snippets": "Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.)",
"criterion": "thyroid variant",
"requirements": [
{
"requirement_type": "type",
"expected_value": [
"poorly differentiated",
"insular",
"tall cell"
]
}
]
},
{
"exact_snippets": "histology has no medullary differentiation",
"criterion": "medullary differentiation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "histology has no ... anaplastic features",
"criterion": "anaplastic features",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors] should be used as a basis for the assessment of disease progression)",
"criterions": [
{
"exact_snippets": "Progression within 14 months",
"criterion": "disease progression",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 14,
"unit": "months"
}
}
]
}
]
},
{
"line": "* RAI (radioactive iodine) refractory",
"criterions": [
{
"exact_snippets": "RAI (radioactive iodine) refractory",
"criterion": "RAI (radioactive iodine)",
"requirements": [
{
"requirement_type": "refractory",
"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": "* Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)",
"criterions": [
{
"exact_snippets": "Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)",
"criterion": "histologic subtypes of thyroid cancer",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": [
"anaplastic carcinoma",
"medullary carcinoma",
"lymphoma",
"sarcoma"
]
}
]
}
]
},
{
"line": "* Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents",
"criterions": [
{
"exact_snippets": "Prior anti-cancer treatment with tyrosine kinase inhibitors",
"criterion": "prior anti-cancer treatment",
"requirements": [
{
"requirement_type": "type",
"expected_value": "tyrosine kinase inhibitors"
}
]
},
{
"exact_snippets": "Prior anti-cancer treatment with ... monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors",
"criterion": "prior anti-cancer treatment",
"requirements": [
{
"requirement_type": "type",
"expected_value": "monoclonal antibodies"
},
{
"requirement_type": "target",
"expected_value": [
"VEGF",
"VEGF Receptors"
]
}
]
},
{
"exact_snippets": "Prior anti-cancer treatment with ... other targeted agents",
"criterion": "prior anti-cancer treatment",
"requirements": [
{
"requirement_type": "type",
"expected_value": "other targeted agents"
}
]
}
]
},
{
"line": "* Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives",
"criterions": [
{
"exact_snippets": "Prior anti-cancer treatment for thyroid cancer with use of chemotherapy",
"criterion": "prior anti-cancer treatment",
"requirements": [
{
"requirement_type": "cancer type",
"expected_value": "thyroid cancer"
},
{
"requirement_type": "treatment type",
"expected_value": "chemotherapy"
}
]
},
{
"exact_snippets": "Prior anti-cancer treatment for thyroid cancer with use of ... Thalidomide or any of its derivatives",
"criterion": "prior anti-cancer treatment",
"requirements": [
{
"requirement_type": "cancer type",
"expected_value": "thyroid cancer"
},
{
"requirement_type": "treatment type",
"expected_value": [
"Thalidomide",
"Thalidomide derivatives"
]
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}