{
    "info": {
        "nct_id": "NCT06167291",
        "official_title": "Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)",
        "inclusion_criteria": "* Newly diagnosed histopathologically-proven p16+ and/or HPV+ HNSCC of the base of tongue or faucial tonsil\n* cT1-2N0-1 per AJCC 8th edition staging.\n* Tumor does not cross midline, and must be >1cm from midline\n* For tonsil tumors, the primary may extend onto the palate or into the BOT but still be >1cm from midline\n* No evidence of contralateral neck disease on contrast MRI, CT Head/Neck, PET/CT, or lymphoscintigraphy nor retropharyngeal lymphadenopathy.\n* Able to undergo lymphoscintigraphy procedure\n* No contraindications for SLNM, adjuvant chemotherapy, RT nor adjuvant/definitive radiotherapy.\n* ECOG 0-1\n* Age >18 years\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Previous HN Cancer except small skin cancers.\n* Any retropharyngeal lymphadenopathy on either MRI, CT, or PET/CT\n* Contralateral neck nodal disease radiographically detected per routine diagnostic imaging or SPECT-CT.\n* Distant metastatic spread at the time of inclusion\n* Chemotherapy or surgery (for the present tumor), prior to inclusion.\n* Previous radiation treatment in the head and neck region, for any reason, except for cutaneous lesions that would not lead to overlap with definitive bilateral neck irradiation\n* Previous thyroidectomy or neck dissection (causes aberrant nodal drainage)\n* Recurrent or second primary tumor in the head and neck region\n* Non-tongue base or non-faucial tonsil primaries\n* Prior history of regionally advanced or distant spread cancers\n* Pregnancy or no active contraception for pre-menopausal women\n* Known hypersensitivity to iodine or nanocolloid injection\n* Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Newly diagnosed histopathologically-proven p16+ and/or HPV+ HNSCC of the base of tongue or faucial tonsil",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histopathologically-proven",
                    "criterion": "diagnosis confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histopathological"
                        }
                    ]
                },
                {
                    "exact_snippets": "p16+",
                    "criterion": "p16 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HPV+",
                    "criterion": "HPV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HNSCC",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "HNSCC"
                        }
                    ]
                },
                {
                    "exact_snippets": "base of tongue",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "base of tongue"
                        }
                    ]
                },
                {
                    "exact_snippets": "faucial tonsil",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "faucial tonsil"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* cT1-2N0-1 per AJCC 8th edition staging.",
            "criterions": [
                {
                    "exact_snippets": "cT1-2",
                    "criterion": "tumor size and extent",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0-1",
                    "criterion": "regional lymph nodes involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "per AJCC 8th edition staging",
                    "criterion": "staging system",
                    "requirements": [
                        {
                            "requirement_type": "version",
                            "expected_value": "AJCC 8th edition"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For tonsil tumors, the primary may extend onto the palate or into the BOT but still be >1cm from midline",
            "criterions": [
                {
                    "exact_snippets": "tonsil tumors",
                    "criterion": "tonsil tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary may extend onto the palate",
                    "criterion": "primary tumor extension onto the palate",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary may extend ... into the BOT",
                    "criterion": "primary tumor extension into the BOT",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": ">1cm from midline",
                    "criterion": "distance from midline",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of contralateral neck disease on contrast MRI, CT Head/Neck, PET/CT, or lymphoscintigraphy nor retropharyngeal lymphadenopathy.",
            "criterions": [
                {
                    "exact_snippets": "No evidence of contralateral neck disease on contrast MRI, CT Head/Neck, PET/CT, or lymphoscintigraphy",
                    "criterion": "contralateral neck disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nor retropharyngeal lymphadenopathy",
                    "criterion": "retropharyngeal lymphadenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to undergo lymphoscintigraphy procedure",
            "criterions": [
                {
                    "exact_snippets": "Able to undergo lymphoscintigraphy procedure",
                    "criterion": "lymphoscintigraphy procedure",
                    "requirements": [
                        {
                            "requirement_type": "ability to undergo",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No contraindications for SLNM, adjuvant chemotherapy, RT nor adjuvant/definitive radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "No contraindications for SLNM",
                    "criterion": "SLNM contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No contraindications for ... adjuvant chemotherapy",
                    "criterion": "adjuvant chemotherapy contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No contraindications for ... RT",
                    "criterion": "RT contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No contraindications for ... adjuvant/definitive radiotherapy",
                    "criterion": "adjuvant/definitive radiotherapy contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >18 years",
            "criterions": [
                {
                    "exact_snippets": "Age >18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Previous HN Cancer except small skin cancers.",
            "criterions": [
                {
                    "exact_snippets": "Previous HN Cancer",
                    "criterion": "previous HN cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except small skin cancers",
                    "criterion": "small skin cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any retropharyngeal lymphadenopathy on either MRI, CT, or PET/CT",
            "criterions": [
                {
                    "exact_snippets": "retropharyngeal lymphadenopathy",
                    "criterion": "retropharyngeal lymphadenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI, CT, or PET/CT",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "MRI",
                                "CT",
                                "PET/CT"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contralateral neck nodal disease radiographically detected per routine diagnostic imaging or SPECT-CT.",
            "criterions": [
                {
                    "exact_snippets": "Contralateral neck nodal disease radiographically detected",
                    "criterion": "contralateral neck nodal disease",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "routine diagnostic imaging",
                                "SPECT-CT"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Distant metastatic spread at the time of inclusion",
            "criterions": [
                {
                    "exact_snippets": "Distant metastatic spread",
                    "criterion": "distant metastatic spread",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy or surgery (for the present tumor), prior to inclusion.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy ... prior to inclusion.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgery (for the present tumor) ... prior to inclusion.",
                    "criterion": "surgery for the present tumor",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous radiation treatment in the head and neck region, for any reason, except for cutaneous lesions that would not lead to overlap with definitive bilateral neck irradiation",
            "criterions": [
                {
                    "exact_snippets": "Previous radiation treatment in the head and neck region",
                    "criterion": "previous radiation treatment",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "head and neck region"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for cutaneous lesions that would not lead to overlap with definitive bilateral neck irradiation",
                    "criterion": "cutaneous lesions",
                    "requirements": [
                        {
                            "requirement_type": "overlap with definitive bilateral neck irradiation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous thyroidectomy or neck dissection (causes aberrant nodal drainage)",
            "criterions": [
                {
                    "exact_snippets": "Previous thyroidectomy",
                    "criterion": "thyroidectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neck dissection",
                    "criterion": "neck dissection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrent or second primary tumor in the head and neck region",
            "criterions": [
                {
                    "exact_snippets": "Recurrent ... tumor in the head and neck region",
                    "criterion": "recurrent tumor",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "head and neck region"
                        }
                    ]
                },
                {
                    "exact_snippets": "second primary tumor in the head and neck region",
                    "criterion": "second primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "head and neck region"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-tongue base or non-faucial tonsil primaries",
            "criterions": [
                {
                    "exact_snippets": "Non-tongue base",
                    "criterion": "tongue base primary",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-faucial tonsil primaries",
                    "criterion": "faucial tonsil primary",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior history of regionally advanced or distant spread cancers",
            "criterions": [
                {
                    "exact_snippets": "Prior history of regionally advanced or distant spread cancers",
                    "criterion": "cancer history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or no active contraception for pre-menopausal women",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no active contraception for pre-menopausal women",
                    "criterion": "active contraception for pre-menopausal women",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to iodine or nanocolloid injection",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to iodine",
                    "criterion": "hypersensitivity to iodine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity to ... nanocolloid injection",
                    "criterion": "hypersensitivity to nanocolloid injection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "Having any condition (physical, mental, sociological) that interferes with the informed consent procedure and follow-up schedules",
                    "criterion": "condition interfering with informed consent and follow-up",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease",
                    "criterion": "active rheumatologic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the treating radiation oncologist precludes safe radiation therapy",
                    "criterion": "opinion of treating radiation oncologist on safe radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "does not preclude safe radiation therapy"
                        }
                    ]
                }
            ]
        },
        {
            "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": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Tumor does not cross midline, and must be >1cm from midline",
            "criterions": [
                {
                    "exact_snippets": "Tumor does not cross midline",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "crossing midline",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor ... >1cm from midline",
                    "criterion": "tumor distance from midline",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}