[96a5a0]: / output / allTrials / identified / NCT00171873_identified.json

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{
"info": {
"nct_id": "NCT00171873",
"official_title": "Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut",
"inclusion_criteria": "* Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut\n* curative surgery impossible\n* two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)\n* Age ≥ 18\n* Karnofsky-index > 60\n* written informed consent\n* proliferation index for Ki67\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* hypersensitivity to octreotide\n* poorly differentiated or small cell neuroendocrine tumors\n* primary tumor outside of the midgut\n* prior treatment with somatostatin-analogue > 4 weeks\n* prior treatment with alpha-interferon, chemotherapy, or chemoembolisation\n* participation in any other clinical trial\n* pregnancy or lactation\n* no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years\n* severe decompensated organ malfunction (heart-, liver- insufficiency)\n\nOther protocol-defined exclusion criteria may apply.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut",
"criterions": [
{
"exact_snippets": "Therapy-naive patients",
"criterion": "therapy-naive",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "histologically confirmed diagnosis",
"criterion": "histological confirmation",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
}
]
},
{
"exact_snippets": "locally inoperable or metastasized",
"criterion": "tumor operability",
"requirements": [
{
"requirement_type": "operability",
"expected_value": "locally inoperable or metastasized"
}
]
},
{
"exact_snippets": "well-differentiated neuroendocrine tumor",
"criterion": "tumor differentiation",
"requirements": [
{
"requirement_type": "differentiation",
"expected_value": "well-differentiated"
}
]
},
{
"exact_snippets": "neuroendocrine tumor of the midgut",
"criterion": "tumor location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "midgut"
}
]
}
]
},
{
"line": "* curative surgery impossible",
"criterions": [
{
"exact_snippets": "curative surgery impossible",
"criterion": "curative surgery",
"requirements": [
{
"requirement_type": "possibility",
"expected_value": false
}
]
}
]
},
{
"line": "* two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)",
"criterions": [
{
"exact_snippets": "two-dimensional tumor formation",
"criterion": "tumor formation",
"requirements": [
{
"requirement_type": "dimensionality",
"expected_value": "two-dimensional"
}
]
},
{
"exact_snippets": "assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)",
"criterion": "imaging modality",
"requirements": [
{
"requirement_type": "assessability",
"expected_value": [
"Computed Tomography (CT)",
"Magnetic Resonance Imaging (MRI)"
]
}
]
}
]
},
{
"line": "* Age ≥ 18",
"criterions": [
{
"exact_snippets": "Age ≥ 18",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Karnofsky-index > 60",
"criterions": [
{
"exact_snippets": "Karnofsky-index > 60",
"criterion": "Karnofsky-index",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* written informed consent",
"criterions": [
{
"exact_snippets": "written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "form",
"expected_value": "written"
}
]
}
]
},
{
"line": "* proliferation index for Ki67",
"criterions": [
{
"exact_snippets": "proliferation index for Ki67",
"criterion": "Ki67",
"requirements": [
{
"requirement_type": "proliferation index",
"expected_value": "N/A"
}
]
}
]
},
{
"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": "* hypersensitivity to octreotide",
"criterions": [
{
"exact_snippets": "hypersensitivity to octreotide",
"criterion": "hypersensitivity to octreotide",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* poorly differentiated or small cell neuroendocrine tumors",
"criterions": [
{
"exact_snippets": "poorly differentiated ... neuroendocrine tumors",
"criterion": "neuroendocrine tumors",
"requirements": [
{
"requirement_type": "differentiation",
"expected_value": "poorly differentiated"
}
]
},
{
"exact_snippets": "small cell neuroendocrine tumors",
"criterion": "neuroendocrine tumors",
"requirements": [
{
"requirement_type": "cell type",
"expected_value": "small cell"
}
]
}
]
},
{
"line": "* primary tumor outside of the midgut",
"criterions": [
{
"exact_snippets": "primary tumor outside of the midgut",
"criterion": "primary tumor location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "outside of the midgut"
}
]
}
]
},
{
"line": "* prior treatment with somatostatin-analogue > 4 weeks",
"criterions": [
{
"exact_snippets": "prior treatment with somatostatin-analogue > 4 weeks",
"criterion": "prior treatment with somatostatin-analogue",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* prior treatment with alpha-interferon, chemotherapy, or chemoembolisation",
"criterions": [
{
"exact_snippets": "prior treatment with alpha-interferon",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "alpha-interferon"
}
]
},
{
"exact_snippets": "prior treatment with ... chemotherapy",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "chemotherapy"
}
]
},
{
"exact_snippets": "prior treatment with ... chemoembolisation",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "chemoembolisation"
}
]
}
]
},
{
"line": "* participation in any other clinical trial",
"criterions": [
{
"exact_snippets": "participation in any other clinical trial",
"criterion": "participation in other clinical trials",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* pregnancy or lactation",
"criterions": [
{
"exact_snippets": "pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactation",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years",
"criterions": [
{
"exact_snippets": "no secondary malignancy in anamnesis",
"criterion": "secondary malignancy in anamnesis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years",
"criterion": "manifestation of secondary malignancy after curative therapy",
"requirements": [
{
"requirement_type": "time since last manifestation",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 5,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* severe decompensated organ malfunction (heart-, liver- insufficiency)",
"criterions": [
{
"exact_snippets": "severe decompensated organ malfunction (heart-",
"criterion": "heart malfunction",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "compensation",
"expected_value": "decompensated"
}
]
},
{
"exact_snippets": "severe decompensated organ malfunction (heart-, liver-",
"criterion": "liver malfunction",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
},
{
"requirement_type": "compensation",
"expected_value": "decompensated"
}
]
}
]
},
{
"line": "Other protocol-defined exclusion criteria may apply.",
"criterions": [
{
"exact_snippets": "Other protocol-defined exclusion criteria",
"criterion": "protocol-defined exclusion criteria",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}