{
"info": {
"nct_id": "NCT00417976",
"official_title": "A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer",
"inclusion_criteria": "* Males or females age >=18 years.\n* Established histological confirmation of adenocarcinoma of the pancreas.\n* Stage III and stage IV will be allowed.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* No prior chemotherapy or radiotherapy allowed except for that given as part of an adjuvant regimen if >4 weeks have elapsed since the end of therapy. Any prior treatment with antibodies to VEGF.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting the study.\n* Pregnant or lactating women.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Males or females age >=18 years.",
"criterions": [
{
"exact_snippets": "Males or females",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "age >=18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Established histological confirmation of adenocarcinoma of the pancreas.",
"criterions": [
{
"exact_snippets": "Established histological confirmation of adenocarcinoma of the pancreas.",
"criterion": "adenocarcinoma of the pancreas",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histological"
}
]
}
]
},
{
"line": "* Stage III and stage IV will be allowed.",
"criterions": [
{
"exact_snippets": "Stage III and stage IV will be allowed.",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "allowed_stages",
"expected_value": [
"III",
"IV"
]
}
]
}
]
},
{
"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": "* No prior chemotherapy or radiotherapy allowed except for that given as part of an adjuvant regimen if >4 weeks have elapsed since the end of therapy. Any prior treatment with antibodies to VEGF.",
"criterions": [
{
"exact_snippets": "No prior chemotherapy",
"criterion": "prior chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No prior ... radiotherapy",
"criterion": "prior radiotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "except for that given as part of an adjuvant regimen if >4 weeks have elapsed since the end of therapy",
"criterion": "adjuvant regimen chemotherapy or radiotherapy",
"requirements": [
{
"requirement_type": "time since end of therapy",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "Any prior treatment with antibodies to VEGF",
"criterion": "prior treatment with antibodies to VEGF",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting the study.",
"criterions": [
{
"exact_snippets": "Major surgical procedure",
"criterion": "major surgical procedure",
"requirements": [
{
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
]
},
{
"exact_snippets": "open biopsy",
"criterion": "open biopsy",
"requirements": [
{
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
]
},
{
"exact_snippets": "significant traumatic injury",
"criterion": "significant traumatic injury",
"requirements": [
{
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Pregnant or lactating women.",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "lactating",
"criterion": "lactation",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}