{
    "info": {
        "nct_id": "NCT00101582",
        "official_title": "Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Radiotherapy With Concurrent Chemotherapy (RT/CT)",
        "inclusion_criteria": "* Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx\n* Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality\n* At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized\n* Concurrent chemotherapy regimen of Cisplatin 100mg/m^2 on days 1, 22, and 43\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2\n* Adequate hematologic, renal and hepatic function\n* Negative pregnancy test by serum or urine\n* Signed informed consent\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "- Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx",
            "criterions": [
                {
                    "exact_snippets": "Histologically documented squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "nasopharynx",
                                "hypopharynx",
                                "larynx"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced stage head and neck cancer",
                    "criterion": "cancer type and stage",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "head and neck cancer"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable/unresected disease",
                    "criterion": "resectability of disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "unresectable",
                                "unresected"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB",
                    "criterion": "AJCC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IVA",
                                "IVB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality",
                    "criterion": "treatment modality suitability",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": "amenable to radiotherapy with concurrent chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized",
            "criterions": [
                {
                    "exact_snippets": "At least 50 Gray of radiation treatment",
                    "criterion": "radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "Gray"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "areas of the oral cavity/oropharynx mucosa that can be visualized",
                    "criterion": "oral cavity/oropharynx mucosa",
                    "requirements": [
                        {
                            "requirement_type": "visibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent chemotherapy regimen of Cisplatin 100mg/m^2 on days 1, 22, and 43",
            "criterions": [
                {
                    "exact_snippets": "Concurrent chemotherapy regimen of Cisplatin 100mg/m^2 on days 1, 22, and 43",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "drug",
                            "expected_value": "Cisplatin"
                        },
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "=",
                                "value": 100,
                                "unit": "mg/m^2"
                            }
                        },
                        {
                            "requirement_type": "schedule",
                            "expected_value": [
                                "day 1",
                                "day 22",
                                "day 43"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic, renal and hepatic function",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... function",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test by serum or urine",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum or urine",
                    "criterion": "pregnancy test method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "serum",
                                "urine"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "- Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)",
            "criterions": [
                {
                    "exact_snippets": "Presence or history of any other primary malignancy",
                    "criterion": "other primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma of the skin without evidence of disease for greater than 3 years",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "disease evidence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ]
}