{
    "info": {
        "nct_id": "NCT00313560",
        "official_title": "Phase II Study of Erlotinib (TarcevaTM) Combined With Chemoradiation and Adjuvant Chemotherapy in Patients With Resectable Pancreatic Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria\n\n1. Resection of a stage I/II pancreatic adenocarcinoma of the pancreas (R0/R1) and a candidate to receive postoperative adjuvant chemoradiation. R2 (laparoscopic resection) based on the surgeons operative note will be excluded from the study.\n2. Aged 18 years or older.\n3. ECOG performance status < 1.\n4. The effects of Erlotinib and Capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n5. Patients must have normal organ and marrow function.\n6. Provision of written informed consent\n7. Patients must have a working knowledge of English in order to complete the quality of life questionnaires. Patients that do not meet this requirement will be exempt from the QoL assessment, but remain eligible for all other components of the study.\n\nExclusion criteria\n\n1. Known severe hypersensitivity to Erlotinib any of the excipient of this product. Hypersensitivity to Capecitabine, doxifluridine, or 5-FU.\n2. Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma, non-invasive early stage bladder cancer (<T1), and cervical cancer in situ.\n3. Uncontrolled, intercurrent illness including (but not limited to) ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n4. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort. Careful monitoring of PT/INR must be done for patients taking Warfarin.\n5. Incomplete healing from previous oncologic or other major surgery.\n6. Gastrointestinal tract disease resulting in an inability to take oral medication.\n7. Pregnant women are excluded from this study because Erlotinib is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Erlotinib, breastfeeding should be discontinued if the mother is treated with Erlotinib. Capecitabine is also potentially teratogenic and its metabolites can be found in breast milk.\n8. Patients with known AIDS or who are HIV-positive on anti-retroviral therapy are excluded since patients' immune deficiency are at increased risk of lethal infection when treated with marrow-suppressive therapy, and interactions between Erlotinib and anti-retroviral therapy are unknown. If patients have known risk factors of HIV they should be tested based on the discretion of the treating oncologist.\n9. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).\n10. Previous radiation to the abdomen.\n11. Previous chemotherapy for pancreatic cancer."
    },
    "inclusion_lines": [
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Resection of a stage I/II pancreatic adenocarcinoma of the pancreas (R0/R1) and a candidate to receive postoperative adjuvant chemoradiation. R2 (laparoscopic resection) based on the surgeons operative note will be excluded from the study.",
            "criterions": [
                {
                    "exact_snippets": "Resection of a stage I/II pancreatic adenocarcinoma of the pancreas (R0/R1)",
                    "criterion": "pancreatic adenocarcinoma resection",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        },
                        {
                            "requirement_type": "resection margin",
                            "expected_value": [
                                "R0",
                                "R1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "candidate to receive postoperative adjuvant chemoradiation",
                    "criterion": "postoperative adjuvant chemoradiation candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "R2 (laparoscopic resection) based on the surgeons operative note will be excluded",
                    "criterion": "R2 laparoscopic resection",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Aged 18 years or older.",
            "criterions": [
                {
                    "exact_snippets": "Aged 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG performance status < 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status < 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. The effects of Erlotinib and Capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.",
            "criterions": [
                {
                    "exact_snippets": "women of child-bearing potential",
                    "criterion": "women of child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "men must agree to use adequate contraception",
                    "criterion": "men",
                    "requirements": [
                        {
                            "requirement_type": "contraception use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients must have normal organ and marrow function.",
            "criterions": [
                {
                    "exact_snippets": "normal organ and marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal organ and marrow function",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Provision of written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Provision of written informed consent",
                    "criterion": "written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients must have a working knowledge of English in order to complete the quality of life questionnaires. Patients that do not meet this requirement will be exempt from the QoL assessment, but remain eligible for all other components of the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have a working knowledge of English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "proficiency",
                            "expected_value": "working knowledge"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Known severe hypersensitivity to Erlotinib any of the excipient of this product. Hypersensitivity to Capecitabine, doxifluridine, or 5-FU.",
            "criterions": [
                {
                    "exact_snippets": "Known severe hypersensitivity to Erlotinib",
                    "criterion": "hypersensitivity to Erlotinib",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of the excipient of this product",
                    "criterion": "hypersensitivity to excipients of Erlotinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to Capecitabine",
                    "criterion": "hypersensitivity to Capecitabine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... doxifluridine",
                    "criterion": "hypersensitivity to doxifluridine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypersensitivity to ... 5-FU",
                    "criterion": "hypersensitivity to 5-FU",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma, non-invasive early stage bladder cancer (<T1), and cervical cancer in situ.",
            "criterions": [
                {
                    "exact_snippets": "Other coexisting malignancies",
                    "criterion": "coexisting malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malignancies diagnosed within the last 5 years",
                    "criterion": "malignancies diagnosed within the last 5 years",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-invasive early stage bladder cancer (<T1)",
                    "criterion": "non-invasive early stage bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "T"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical cancer in situ",
                    "criterion": "cervical cancer in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Uncontrolled, intercurrent illness including (but not limited to) ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled, intercurrent illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled, intercurrent illness ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled, intercurrent illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled, intercurrent illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled, intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort. Careful monitoring of PT/INR must be done for patients taking Warfarin.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort.",
                    "criterion": "concomitant use of specific drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "phenytoin",
                                "carbamazepine",
                                "barbiturates",
                                "rifampicin",
                                "phenobarbital",
                                "St John's Wort"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Careful monitoring of PT/INR ... patients taking Warfarin.",
                    "criterion": "PT/INR monitoring",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Incomplete healing from previous oncologic or other major surgery.",
            "criterions": [
                {
                    "exact_snippets": "Incomplete healing from previous oncologic or other major surgery.",
                    "criterion": "healing from previous surgery",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Gastrointestinal tract disease resulting in an inability to take oral medication.",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal tract disease",
                    "criterion": "gastrointestinal tract disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "resulting in an inability to take oral medication",
                    "criterion": "ability to take oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnant women are excluded from this study because Erlotinib is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Erlotinib, breastfeeding should be discontinued if the mother is treated with Erlotinib. Capecitabine is also potentially teratogenic and its metabolites can be found in breast milk.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding should be discontinued",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with known AIDS or who are HIV-positive on anti-retroviral therapy are excluded since patients' immune deficiency are at increased risk of lethal infection when treated with marrow-suppressive therapy, and interactions between Erlotinib and anti-retroviral therapy are unknown. If patients have known risk factors of HIV they should be tested based on the discretion of the treating oncologist.",
            "criterions": [
                {
                    "exact_snippets": "Patients with known AIDS",
                    "criterion": "AIDS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV-positive on anti-retroviral therapy",
                    "criterion": "HIV-positive on anti-retroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients' immune deficiency",
                    "criterion": "immune deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "interactions between Erlotinib and anti-retroviral therapy",
                    "criterion": "interactions between Erlotinib and anti-retroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "unknown",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known risk factors of HIV",
                    "criterion": "risk factors of HIV",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).",
            "criterions": [
                {
                    "exact_snippets": "clinically active interstitial lung disease",
                    "criterion": "clinically active interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic stable radiographic changes",
                    "criterion": "chronic stable radiographic changes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic",
                    "criterion": "asymptomatic",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Previous radiation to the abdomen.",
            "criterions": [
                {
                    "exact_snippets": "Previous radiation to the abdomen",
                    "criterion": "radiation to the abdomen",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Previous chemotherapy for pancreatic cancer.",
            "criterions": [
                {
                    "exact_snippets": "Previous chemotherapy for pancreatic cancer.",
                    "criterion": "previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "pancreatic cancer"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria",
            "criterions": []
        },
        {
            "line": "Exclusion criteria",
            "criterions": []
        }
    ]
}