{
    "info": {
        "nct_id": "NCT03892720",
        "official_title": "A Phase II Study of Non-Coplanar SBRT Re-Irradiation Using HyperArc in Patients With Recurrent Head and Neck Cancer",
        "inclusion_criteria": "* Histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery.\n* History of radiation therapy for head and neck cancer with minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume.\n* Estimated life expectancy > 12 weeks.\n* Karnofsky performance status >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2).\n* Maximum tumor, or tumor bed, diameter < 5 cm.\n* If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment.\n* Ability to understand and willingness to sign a written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed recurrent head and neck cancer",
                    "criterion": "recurrent head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "either unresectable or status post salvage surgery",
                    "criterion": "head and neck cancer resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability status",
                            "expected_value": [
                                "unresectable",
                                "status post salvage surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of radiation therapy for head and neck cancer with minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume.",
            "criterions": [
                {
                    "exact_snippets": "History of radiation therapy for head and neck cancer",
                    "criterion": "radiation therapy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume",
                    "criterion": "isodose line overlap",
                    "requirements": [
                        {
                            "requirement_type": "percentage overlap",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated life expectancy > 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy > 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status >= 70 (Eastern Cooperative Oncology Group [ECOG] 0-2).",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status >= 70",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group [ECOG] 0-2",
                    "criterion": "Eastern Cooperative Oncology Group (ECOG) performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Maximum tumor, or tumor bed, diameter < 5 cm.",
            "criterions": [
                {
                    "exact_snippets": "Maximum tumor, or tumor bed, diameter < 5 cm.",
                    "criterion": "tumor or tumor bed diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment.",
            "criterions": [
                {
                    "exact_snippets": "If a woman is of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a negative serum pregnancy test must be documented",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence)",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "hormonal",
                                "barrier",
                                "abstinence"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for duration of study participation and for up to 4 weeks following the study treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "for duration of study participation and for up to 4 weeks following the study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and willingness to sign a written informed consent.",
            "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",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}