{
    "info": {
        "nct_id": "NCT02595320",
        "official_title": "Randomized Open-label Trial of Dose Dense, Fixed Dose Capecitabine Compared to Standard Dose Capecitabine in Metastatic Breast Cancer and Advanced/Metastatic Gastrointestinal Cancers.",
        "inclusion_criteria": "* Women with metastatic breast cancer OR men and women with metastatic gastrointestinal (GI) cancer\n* There is no limit to the number of prior chemotherapy or endocrine therapy regimens received. Use of a previous fluoropyrimidine-containing regimen in advanced / metastatic setting is permitted as long as the subject discontinued the regimen for reasons other than progression.\n* No restriction on the use of fluoropyrimidine-containing regimen in the neoadjuvant or adjuvant setting\n* For metastatic colorectal cancers, patients starting maintenance capecitabine after a course of oxaliplatin or irinotecan based chemotherapy are eligible.\n* Measurable or non-measurable disease per RECIST criteria 1.1\n* Must have completed prior chemotherapy or radiation therapy at least 2 weeks prior to registration\n* Pathologic confirmation of respective malignancies. Biopsy of metastatic disease is preferred but not mandatory.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0-2\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,000/ microLiter (uL)\n  * hemoglobin ≥ 7 g/L\n  * platelets ≥ 50,000/uL\n  * total bilirubin ≤ 2 X the Institutional Upper Limit of Normal (IULN)\n  * o Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase [SGOT]) ≤ 5 X IULN\n  * Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase [SPGT]) ≤ 5 X IULN\n  * creatinine clearance > 50 milliliters per minute (ml/min)\n* Women of childbearing potential must agree to use adequate contraception.\n* Subjects may have previously treated brain or Central Nervous System (CNS) metastasis with radiation completed at least 2 weeks prior to registration. Prior radiation to places other than CNS disease must be completed at least 14 days prior to registration. Any number of prior radiation therapy regimens is allowed provided all toxicity of prior therapy is resolved to grade 1 or less.\n* Life expectancy of >3 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patient has used Capecitabine in a past regimen for metastatic disease.\n* Patient is currently using, or planning to use another investigational agent.\n* Patient with known Dihydropyrimidine Dehydrogenase (DPD) deficiency\n* Patient has symptomatic brain or CNS metastases.\n* Patient has leptomeningeal disease\n* Patient is pregnant or nursing\n* Subjects must have no barriers to taking oral medications, for example uncontrolled nausea, vomiting, diarrhea at baseline, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome.\n* No recent (≤ 3months) of partial or complete bowel obstruction unless surgically corrected.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Women with metastatic breast cancer OR men and women with metastatic gastrointestinal (GI) cancer",
            "criterions": [
                {
                    "exact_snippets": "Women with metastatic breast cancer",
                    "criterion": "gender and cancer type",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "cancer type",
                            "expected_value": "metastatic breast cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "men and women with metastatic gastrointestinal (GI) cancer",
                    "criterion": "gender and cancer type",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        },
                        {
                            "requirement_type": "cancer type",
                            "expected_value": "metastatic gastrointestinal (GI) cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* There is no limit to the number of prior chemotherapy or endocrine therapy regimens received. Use of a previous fluoropyrimidine-containing regimen in advanced / metastatic setting is permitted as long as the subject discontinued the regimen for reasons other than progression.",
            "criterions": [
                {
                    "exact_snippets": "no limit to the number of prior chemotherapy or endocrine therapy regimens received",
                    "criterion": "prior chemotherapy or endocrine therapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "no limit"
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of a previous fluoropyrimidine-containing regimen in advanced / metastatic setting is permitted",
                    "criterion": "previous fluoropyrimidine-containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "subject discontinued the regimen for reasons other than progression",
                    "criterion": "discontinuation of previous fluoropyrimidine-containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "reason for discontinuation",
                            "expected_value": "other than progression"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No restriction on the use of fluoropyrimidine-containing regimen in the neoadjuvant or adjuvant setting",
            "criterions": [
                {
                    "exact_snippets": "No restriction on the use of fluoropyrimidine-containing regimen",
                    "criterion": "use of fluoropyrimidine-containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "restriction",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For metastatic colorectal cancers, patients starting maintenance capecitabine after a course of oxaliplatin or irinotecan based chemotherapy are eligible.",
            "criterions": [
                {
                    "exact_snippets": "metastatic colorectal cancers",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "metastatic colorectal cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients starting maintenance capecitabine",
                    "criterion": "treatment",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "capecitabine"
                        },
                        {
                            "requirement_type": "phase",
                            "expected_value": "maintenance"
                        }
                    ]
                },
                {
                    "exact_snippets": "after a course of oxaliplatin or irinotecan based chemotherapy",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "oxaliplatin",
                                "irinotecan"
                            ]
                        },
                        {
                            "requirement_type": "phase",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable or non-measurable disease per RECIST criteria 1.1",
            "criterions": [
                {
                    "exact_snippets": "Measurable or non-measurable disease per RECIST criteria 1.1",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        },
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST criteria 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have completed prior chemotherapy or radiation therapy at least 2 weeks prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Must have completed prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 2 weeks prior to registration",
                    "criterion": "time since prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathologic confirmation of respective malignancies. Biopsy of metastatic disease is preferred but not mandatory.",
            "criterions": [
                {
                    "exact_snippets": "Pathologic confirmation of respective malignancies.",
                    "criterion": "pathologic confirmation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Biopsy of metastatic disease is preferred but not mandatory.",
                    "criterion": "biopsy of metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": "preferred"
                        },
                        {
                            "requirement_type": "mandatory",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0-2",
            "criterions": [
                {
                    "exact_snippets": "Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 0-2",
                    "criterion": "ECOG Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and marrow function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,000/ microLiter (uL)",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,000/ microLiter (uL)",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "microLiter (uL)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hemoglobin ≥ 7 g/L",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin ≥ 7 g/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platelets ≥ 50,000/uL",
            "criterions": [
                {
                    "exact_snippets": "platelets ≥ 50,000/uL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50000,
                                "unit": "uL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* total bilirubin ≤ 2 X the Institutional Upper Limit of Normal (IULN)",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin ≤ 2 X the Institutional Upper Limit of Normal (IULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "X IULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* o Aspartate Aminotransferase (AST) ( Serum Glutamic Oxaloacetic Transaminase [SGOT]) ≤ 5 X IULN",
            "criterions": [
                {
                    "exact_snippets": "Aspartate Aminotransferase (AST) ... ≤ 5 X IULN",
                    "criterion": "Aspartate Aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "X IULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase [SPGT]) ≤ 5 X IULN",
            "criterions": [
                {
                    "exact_snippets": "Alanine Aminotransferase (ALT) (Serum Pyruvic Glutamic Transaminase [SPGT]) ≤ 5 X IULN",
                    "criterion": "Alanine Aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "X IULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* creatinine clearance > 50 milliliters per minute (ml/min)",
            "criterions": [
                {
                    "exact_snippets": "creatinine clearance > 50 milliliters per minute (ml/min)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "milliliters per minute (ml/min)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must agree to use adequate contraception.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects may have previously treated brain or Central Nervous System (CNS) metastasis with radiation completed at least 2 weeks prior to registration. Prior radiation to places other than CNS disease must be completed at least 14 days prior to registration. Any number of prior radiation therapy regimens is allowed provided all toxicity of prior therapy is resolved to grade 1 or less.",
            "criterions": [
                {
                    "exact_snippets": "Subjects may have previously treated brain or Central Nervous System (CNS) metastasis",
                    "criterion": "previously treated brain or CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation completed at least 2 weeks prior to registration",
                    "criterion": "radiation completion for brain or CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior radiation to places other than CNS disease must be completed at least 14 days prior to registration",
                    "criterion": "radiation completion for non-CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any number of prior radiation therapy regimens is allowed",
                    "criterion": "number of prior radiation therapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "all toxicity of prior therapy is resolved to grade 1 or less",
                    "criterion": "toxicity of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of >3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of >3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patient has used Capecitabine in a past regimen for metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Patient has used Capecitabine in a past regimen for metastatic disease.",
                    "criterion": "Capecitabine usage",
                    "requirements": [
                        {
                            "requirement_type": "past usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is currently using, or planning to use another investigational agent.",
            "criterions": [
                {
                    "exact_snippets": "Patient is currently using ... another investigational agent.",
                    "criterion": "use of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to use another investigational agent.",
                    "criterion": "use of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "planned use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with known Dihydropyrimidine Dehydrogenase (DPD) deficiency",
            "criterions": [
                {
                    "exact_snippets": "known Dihydropyrimidine Dehydrogenase (DPD) deficiency",
                    "criterion": "Dihydropyrimidine Dehydrogenase (DPD) deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has symptomatic brain or CNS metastases.",
            "criterions": [
                {
                    "exact_snippets": "symptomatic brain or CNS metastases",
                    "criterion": "brain or CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has leptomeningeal disease",
            "criterions": [
                {
                    "exact_snippets": "Patient has leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Patient is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have no barriers to taking oral medications, for example uncontrolled nausea, vomiting, diarrhea at baseline, lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome.",
            "criterions": [
                {
                    "exact_snippets": "no barriers to taking oral medications, for example uncontrolled nausea, vomiting, diarrhea at baseline",
                    "criterion": "barriers to taking oral medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lack of physical integrity of the upper gastrointestinal tract",
                    "criterion": "physical integrity of the upper gastrointestinal tract",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No recent (≤ 3months) of partial or complete bowel obstruction unless surgically corrected.",
            "criterions": [
                {
                    "exact_snippets": "No recent (≤ 3months) of partial or complete bowel obstruction",
                    "criterion": "bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "partial",
                                "complete"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unless surgically corrected",
                    "criterion": "surgical correction of bowel obstruction",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}