{
    "info": {
        "nct_id": "NCT02945631",
        "official_title": "Quarterback 22: A Phase II Clinical Trial of Sequential Therapy and De-Intensified Chemoradiotherapy for Locally Advanced HPV Positive Oropharynx Cancer",
        "inclusion_criteria": "Participants must meet the following criteria to be eligible to participate in the study. Patients may enroll in the study if they meet all of the entry criteria, were candidates for induction chemotherapy regardless of HPV status and have to start therapy for logistic reasons prior to p16 and HPV testing. They will enter the experimental post-Induction portion of the study if the surgical specimens or biopsies are proven to be HPV+ on PCR testing. Patients who are HPV negative will be taken off study and treated with SOC radiotherapy and surgery:\n\n* Participants must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, supraglottic larynx, nasal cavity, unknown primary, or nasopharynx that is p16 and HPV positive. Tissue from the primary site or lymph node must be available for biomarker studies and for PCR testing. IHC must be performed in a lab verified by the central laboratory or the slides must be available for review by the central laboratory and PCR must be done in the central laboratory prior to radiotherapy. HPVPCR must be performed and results available for reduced dose therapy after induction.\n* Patients who are on the Quarterback Trial when Quarterback 2 is activated and who have been randomized to radiotherapy arm will be asked to transfer to this trial and receive the Quarterback 2 defined radiotherapy.\n* Stage 3 or 4 disease without evidence of distant metastases.\n* At least one clinically evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria.\n* Age ≥ 18 years.\n* No previous surgery, radiation therapy or chemotherapy for SSCHN (other than biopsy or tonsillectomy) is allowed at time of study entry.\n* ECOG performance status of 0 or 1.\n* No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity).\n* Participants must have adequate bone marrow, hepatic and renal functions as defined below:\n* - Hematology:\n* - Neutrophil count ≥ 1.5 x 10^9/l.\n* - Platelet count ≥ 100 x 10^9/l.\n* - Hemoglobin ≥ 10g/dl.\n* - Renal function ≥ 60 ml/min (actual or calculated by the Cockcroft-Gault method) as follows: CrCl (ml/min) = (140-age)(weight kg)/(mL/min) / 72 x serum creatinine (mg/dL)\n* - N.B. For females, use 85% of calculated CrCl value. Or a Creatinine ≤ the upper limits of normal\n* - Hepatic:\n* - Total Bilirubin ≤ institutional upper level of normal (ULN)\n* - AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility\n* Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patients with Gilbert's Disease and absent hepatic pathology by history and clinical assessment may be treated on study with bilirubin > the ULN for the institution if other liver functions studies are within the normal range\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter.\n* Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years.\n* Symptomatic peripheral neuropathy grade > 2 by NCI Common Terminology Criteria (NCI-CTC) version 4.\n* Symptomatic altered hearing > grade 2 by NCI-CTCv4 criteria.These patients can be entered by substituting carboplatin for cisplatin with an AUC of 6.0\n* Other serious illnesses or medical conditions including but not limited to:\n* - Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry\n* - History of significant neurologic or psychiatric disorders including dementia or seizures\n* - Active clinically significant uncontrolled infection\n* - Active peptic ulcer disease defined as unhealed or clinically active\n* - Hypercalcemia\n* - Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis\n* - Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor\n* - Autoimmune disease requiring therapy, prior organ transplant, or HIV infection\n* - Interstitial lung disease\n* - Hepatitis C by history, and confirmed by serology\n* Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.\n* Concurrent treatment with any other anticancer therapy.\n* Participation in an investigational therapeutic drug trial within 30 days of study entry.\n* Active smoking or a cumulative pack year history of > 20 pack years, active smoking is (Defined as ≥ 1 cigarette per day) within the last 5 years.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Participants must meet the following criteria to be eligible to participate in the study. Patients may enroll in the study if they meet all of the entry criteria, were candidates for induction chemotherapy regardless of HPV status and have to start therapy for logistic reasons prior to p16 and HPV testing. They will enter the experimental post-Induction portion of the study if the surgical specimens or biopsies are proven to be HPV+ on PCR testing. Patients who are HPV negative will be taken off study and treated with SOC radiotherapy and surgery:",
            "criterions": [
                {
                    "exact_snippets": "candidates for induction chemotherapy",
                    "criterion": "induction chemotherapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "regardless of HPV status",
                    "criterion": "HPV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "start therapy for logistic reasons prior to p16 and HPV testing",
                    "criterion": "therapy start",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to p16 and HPV testing"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical specimens or biopsies are proven to be HPV+ on PCR testing",
                    "criterion": "HPV status on PCR testing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "HPV+"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, supraglottic larynx, nasal cavity, unknown primary, or nasopharynx that is p16 and HPV positive. Tissue from the primary site or lymph node must be available for biomarker studies and for PCR testing. IHC must be performed in a lab verified by the central laboratory or the slides must be available for review by the central laboratory and PCR must be done in the central laboratory prior to radiotherapy. HPVPCR must be performed and results available for reduced dose therapy after induction.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma of the oropharynx, hypopharynx, supraglottic larynx, nasal cavity, unknown primary, or nasopharynx",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "oropharynx",
                                "hypopharynx",
                                "supraglottic larynx",
                                "nasal cavity",
                                "unknown primary",
                                "nasopharynx"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "p16 and HPV positive",
                    "criterion": "p16 and HPV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from the primary site or lymph node must be available",
                    "criterion": "tissue availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "biomarker studies",
                    "criterion": "biomarker studies",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "tissue available"
                        }
                    ]
                },
                {
                    "exact_snippets": "PCR testing",
                    "criterion": "PCR testing",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "tissue available"
                        }
                    ]
                },
                {
                    "exact_snippets": "IHC must be performed in a lab verified by the central laboratory",
                    "criterion": "IHC performance",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "lab verified by the central laboratory"
                        }
                    ]
                },
                {
                    "exact_snippets": "slides must be available for review by the central laboratory",
                    "criterion": "slide availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PCR must be done in the central laboratory prior to radiotherapy",
                    "criterion": "PCR location and timing",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "central laboratory"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to radiotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "HPVPCR must be performed and results available for reduced dose therapy after induction",
                    "criterion": "HPVPCR performance and result availability",
                    "requirements": [
                        {
                            "requirement_type": "performance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "result availability",
                            "expected_value": "for reduced dose therapy after induction"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are on the Quarterback Trial when Quarterback 2 is activated and who have been randomized to radiotherapy arm will be asked to transfer to this trial and receive the Quarterback 2 defined radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are on the Quarterback Trial",
                    "criterion": "participation in Quarterback Trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "who have been randomized to radiotherapy arm",
                    "criterion": "randomization to radiotherapy arm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage 3 or 4 disease without evidence of distant metastases.",
            "criterions": [
                {
                    "exact_snippets": "Stage 3 or 4 disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "without evidence of distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one clinically evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "clinically evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "evaluable",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurable",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous surgery, radiation therapy or chemotherapy for SSCHN (other than biopsy or tonsillectomy) is allowed at time of study entry.",
            "criterions": [
                {
                    "exact_snippets": "No previous surgery ... for SSCHN ... is allowed",
                    "criterion": "previous surgery for SSCHN",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous ... radiation therapy ... for SSCHN ... is allowed",
                    "criterion": "previous radiation therapy for SSCHN",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous ... chemotherapy for SSCHN ... is allowed",
                    "criterion": "previous chemotherapy for SSCHN",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active alcohol addiction (as assessed by medical caregiver and defined as at least 6 months without activity).",
            "criterions": [
                {
                    "exact_snippets": "No active alcohol addiction ... at least 6 months without activity",
                    "criterion": "alcohol addiction",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have adequate bone marrow, hepatic and renal functions as defined below:",
            "criterions": [
                {
                    "exact_snippets": "adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal functions",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Hematology:",
            "criterions": [
                {
                    "exact_snippets": "Hematology",
                    "criterion": "hematology",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Neutrophil count ≥ 1.5 x 10^9/l.",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil count ≥ 1.5 x 10^9/l",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Platelet count ≥ 100 x 10^9/l.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100 x 10^9/l.",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/l"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Hemoglobin ≥ 10g/dl.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 10g/dl.",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Renal function ≥ 60 ml/min (actual or calculated by the Cockcroft-Gault method) as follows: CrCl (ml/min) = (140-age)(weight kg)/(mL/min) / 72 x serum creatinine (mg/dL)",
            "criterions": [
                {
                    "exact_snippets": "Renal function ≥ 60 ml/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - N.B. For females, use 85% of calculated CrCl value. Or a Creatinine ≤ the upper limits of normal",
            "criterions": [
                {
                    "exact_snippets": "females, use 85% of calculated CrCl value",
                    "criterion": "calculated CrCl value for females",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine ≤ the upper limits of normal",
                    "criterion": "Creatinine",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "upper limits of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Total Bilirubin ≤ institutional upper level of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Total Bilirubin ≤ institutional upper level of normal (ULN)",
                    "criterion": "Total Bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility",
            "criterions": [
                {
                    "exact_snippets": "AST or ALT ... must be within the range allowing for eligibility",
                    "criterion": "AST or ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the range allowing for eligibility"
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline Phosphatase must be within the range allowing for eligibility",
                    "criterion": "Alkaline Phosphatase levels",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the range allowing for eligibility"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must have a negative pregnancy test within 7 days of starting treatment.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days of starting treatment",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days of starting treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with Gilbert's Disease and absent hepatic pathology by history and clinical assessment may be treated on study with bilirubin > the ULN for the institution if other liver functions studies are within the normal range",
            "criterions": [
                {
                    "exact_snippets": "Patients with Gilbert's Disease",
                    "criterion": "Gilbert's Disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "absent hepatic pathology by history and clinical assessment",
                    "criterion": "hepatic pathology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bilirubin > the ULN for the institution",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other liver functions studies are within the normal range",
                    "criterion": "other liver function studies",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the normal range"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Pregnant or breast feeding women, or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months thereafter.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women and men of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not willing to use adequate contraception while on treatment and for at least 3 months thereafter",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, or other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years.",
            "criterions": [
                {
                    "exact_snippets": "Previous or current malignancies at other sites",
                    "criterion": "malignancies at other sites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated in situ carcinoma of the cervix",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous cell carcinoma of the skin",
                    "criterion": "basal or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "thyroid cancer",
                    "criterion": "thyroid cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other cancer curatively treated by surgery and with no current evidence of disease for at least 5 years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "curative surgery"
                        },
                        {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic peripheral neuropathy grade > 2 by NCI Common Terminology Criteria (NCI-CTC) version 4.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic peripheral neuropathy grade > 2 by NCI Common Terminology Criteria (NCI-CTC) version 4.",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "symptom presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NCI-CTC grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic altered hearing > grade 2 by NCI-CTCv4 criteria.These patients can be entered by substituting carboplatin for cisplatin with an AUC of 6.0",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic altered hearing > grade 2 by NCI-CTCv4 criteria",
                    "criterion": "altered hearing",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade (NCI-CTCv4)"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other serious illnesses or medical conditions including but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "Other serious illnesses or medical conditions",
                    "criterion": "serious illnesses or medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry",
            "criterions": [
                {
                    "exact_snippets": "Unstable cardiac disease despite treatment",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months prior to study entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - History of significant neurologic or psychiatric disorders including dementia or seizures",
            "criterions": [
                {
                    "exact_snippets": "History of significant neurologic or psychiatric disorders",
                    "criterion": "neurologic or psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "including dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... seizures",
                    "criterion": "seizures",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Active clinically significant uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "Active clinically significant uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Active peptic ulcer disease defined as unhealed or clinically active",
            "criterions": [
                {
                    "exact_snippets": "Active peptic ulcer disease defined as unhealed or clinically active",
                    "criterion": "peptic ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "unhealed",
                                "clinically active"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Hypercalcemia",
            "criterions": [
                {
                    "exact_snippets": "Hypercalcemia",
                    "criterion": "hypercalcemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Active drug addiction including alcohol, cocaine or intravenous drug use",
                    "criterion": "active drug addiction",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": [
                                "alcohol",
                                "cocaine",
                                "intravenous drug use"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "defined as occurring within the 6 months preceding diagnosis",
                    "criterion": "active drug addiction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Chronic Obstructive Pulmonary Disease, defined as being associated with a hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis. This does not include obstruction from tumor",
            "criterions": [
                {
                    "exact_snippets": "Chronic Obstructive Pulmonary Disease",
                    "criterion": "Chronic Obstructive Pulmonary Disease",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "hospitalization for pneumonia or respiratory decompensation within 12 months of diagnosis"
                        }
                    ]
                },
                {
                    "exact_snippets": "obstruction from tumor",
                    "criterion": "obstruction from tumor",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Autoimmune disease requiring therapy, prior organ transplant, or HIV infection",
            "criterions": [
                {
                    "exact_snippets": "Autoimmune disease requiring therapy",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "therapy requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior organ transplant",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "Interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* - Hepatitis C by history, and confirmed by serology",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis C by history, and confirmed by serology",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "serology"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.",
            "criterions": [
                {
                    "exact_snippets": "involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry",
                    "criterion": "involuntary weight loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "% of body weight"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "2 months preceding study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent treatment with any other anticancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with any other anticancer therapy.",
                    "criterion": "concurrent anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in an investigational therapeutic drug trial within 30 days of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Participation in an investigational therapeutic drug trial within 30 days of study entry.",
                    "criterion": "participation in investigational therapeutic drug trial",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active smoking or a cumulative pack year history of > 20 pack years, active smoking is (Defined as ≥ 1 cigarette per day) within the last 5 years.",
            "criterions": [
                {
                    "exact_snippets": "Active smoking",
                    "criterion": "active smoking",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cumulative pack year history of > 20 pack years",
                    "criterion": "cumulative pack year history",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "pack years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active smoking is (Defined as ≥ 1 cigarette per day) within the last 5 years",
                    "criterion": "active smoking within the last 5 years",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cigarette per day"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}