{
"info": {
"nct_id": "NCT01963182",
"official_title": "Phase II Study: Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer",
"inclusion_criteria": "* Colorectal cancer histologically or cytologically proven\n* Indication of treatment according to the FOLFIRI + / - bevacizumab or cetuximab or panitumumab\n* Age> 18 years\n* Presence of at least one measurable target by RECIST\n* Life expectancy> 3 months\n* Satisfactory biological functions (renal, hepatic and hematologic)\n* Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the Act of August 9, 2004\n* Patient has signed, after informing the informed consent form\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients of childbearing age and not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab and patient pregnant or nursing\n* Patient with another pathology deemed incompatible with the entry in the protocol\n* Prior treatment in metastatic\n* Patients taking antiepileptic\n* Allergic reaction or intolerance to irinotecan\n* Heart failure , kidney , bone marrow , liver or respiratory\n* Higher bilirubin 1.5 times the upper limit of normal\n* Significant psychiatric or neurological abnormality\n* Infectious syndrome requiring treatment with antibiotics or antiviral long-term\n* Patients with chronic inflammatory bowel disease and / or bowel obstruction\n* Contraindication Association St. John's wort and yellow fever vaccine\n* Against Heart indication 5-FU\n* Concurrent treatment with a drug test , participation in a clinical trial within <30 days\n* Patient refused to sign the consent",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Colorectal cancer histologically or cytologically proven",
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{
"exact_snippets": "Colorectal cancer histologically or cytologically proven",
"criterion": "colorectal cancer",
"requirement": {
"requirement_type": "confirmation method",
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"histologically",
"cytologically"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Colorectal cancer histologically or cytologically proven",
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"histologically",
"cytologically"
]
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}
]
}
},
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"identified_line": {
"line": "* Age> 18 years",
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{
"exact_snippets": "Age> 18 years",
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"operator": ">",
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"unit": "years"
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}
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"operator": ">",
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"exact_snippets": "Presence of at least one measurable target by RECIST",
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"expected_value": true
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"exact_snippets": "Presence of at least one measurable target by RECIST",
"criterion": "measurable target by RECIST",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
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}
}
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"exact_snippets": "Presence of at least one measurable target by RECIST",
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"exact_snippets": "Presence of at least one measurable target by RECIST",
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"operator": ">=",
"value": 1,
"unit": "N/A"
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"operator": ">",
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"unit": "months"
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"exact_snippets": "Life expectancy> 3 months",
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"operator": ">",
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"unit": "months"
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}
}
]
}
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{
"identified_line": {
"line": "* Satisfactory biological functions (renal, hepatic and hematologic)",
"criterions": [
{
"exact_snippets": "Satisfactory biological functions (renal",
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"requirement_type": "satisfactory",
"expected_value": true
}
},
{
"exact_snippets": "Satisfactory biological functions ... hepatic",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "satisfactory",
"expected_value": true
}
},
{
"exact_snippets": "Satisfactory biological functions ... hematologic",
"criterion": "hematologic function",
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"expected_value": true
}
}
]
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"exact_snippets": "Satisfactory biological functions (renal",
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"expected_value": true
}
},
{
"exact_snippets": "Satisfactory biological functions ... hepatic",
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"expected_value": true
}
},
{
"exact_snippets": "Satisfactory biological functions ... hematologic",
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"expected_value": true
}
}
]
}
},
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"exact_snippets": "Affiliation to a social security scheme (or be the beneficiary of such a plan)",
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}
},
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"exact_snippets": "Affiliation to a social security scheme (or be the beneficiary of such a plan)",
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"identified_line": {
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
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"value": 18,
"unit": "Years"
}
}
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"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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{
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}
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"exact_snippets": "not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab",
"criterion": "use of effective contraception",
"requirement": {
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"expected_value": false
}
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{
"exact_snippets": "patient pregnant",
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"requirement": {
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}
},
{
"exact_snippets": "nursing",
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{
"and_criteria": [
{
"and_criteria": [
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]
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{
"identified_line": {
"line": "* Prior treatment in metastatic",
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}
}
]
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}
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}
}
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}
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"exact_snippets": "Allergic reaction or intolerance to irinotecan",
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]
}
}
]
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]
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}
]
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},
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{
"exact_snippets": "liver",
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}
},
{
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}
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"exact_snippets": "liver",
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]
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"exact_snippets": "Higher bilirubin 1.5 times the upper limit of normal",
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"identified_line": {
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{
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"expected_value": "significant"
}
},
{
"exact_snippets": "Significant ... neurological abnormality",
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}
}
]
},
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}
},
{
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}
}
]
}
},
{
"identified_line": {
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"exact_snippets": "chronic inflammatory bowel disease",
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},
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}
},
{
"exact_snippets": "Contraindication Association ... yellow fever vaccine",
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"exact_snippets": "Contraindication Association ... yellow fever vaccine",
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}
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}
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"identified_line": {
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"exact_snippets": "5-FU",
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],
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}
]
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]
}
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],
"failed_exclusion": [
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"line": "* Patient with another pathology deemed incompatible with the entry in the protocol",
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{
"exact_snippets": "another pathology deemed incompatible with the entry in the protocol",
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}
}
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},
{
"identified_line": {
"line": "* Infectious syndrome requiring treatment with antibiotics or antiviral long-term",
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{
"exact_snippets": "Infectious syndrome requiring treatment with antibiotics or antiviral long-term",
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]
}
},
{
"exact_snippets": "Infectious syndrome requiring treatment with antibiotics or antiviral long-term",
"criterion": "infectious syndrome",
"requirement": {
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Infectious syndrome requiring treatment with antibiotics or antiviral long-term",
"criterion": "infectious syndrome",
"requirement": {
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"expected_value": [
"antibiotics"
]
}
},
{
"exact_snippets": "Infectious syndrome requiring treatment with antibiotics or antiviral long-term",
"criterion": "infectious syndrome",
"requirement": {
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}
}
]
},
{
"and_criteria": [
{
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"criterion": "infectious syndrome",
"requirement": {
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"expected_value": [
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]
}
},
{
"exact_snippets": "Infectious syndrome requiring treatment with antibiotics or antiviral long-term",
"criterion": "infectious syndrome",
"requirement": {
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}
}
]
}
]
}
}
],
"failed_miscellaneous": []
}