{
"info": {
"nct_id": "NCT03847480",
"official_title": "Dose Painting of Head and Neck Cancer - The RADPAINT Pilot Study",
"inclusion_criteria": "Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Oral cavity, hypopharynx cancer, larynx cancer and HPV ((human papillomavirus) negative oropharyngeal cancer.\n\nPatients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with nimorazole hypoxic cell radiosensitizer)\n\nPlanned treatment at the Oslo University Hospital\n\nAge > 18 years\n\nWHO (World Health Organization) performance status 0-2\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "TNM (primary tumor, regional nodes, metastasis) stage cT1 cN0-N1 cM0\n\nGlottic cancer cT1-T2 cN0 cM0\n\nHPV positive oropharyngeal carcinoma\n\nCancer in the soft palate\n\nDiabetes mellitus",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Oral cavity, hypopharynx cancer, larynx cancer and HPV ((human papillomavirus) negative oropharyngeal cancer.",
"criterions": [
{
"exact_snippets": "Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region",
"criterion": "invasive squamous cell carcinoma of the head and neck region",
"requirements": [
{
"requirement_type": "verification method",
"expected_value": [
"histologically",
"cytologically"
]
}
]
},
{
"exact_snippets": "Oral cavity",
"criterion": "oral cavity cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "hypopharynx cancer",
"criterion": "hypopharynx cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "larynx cancer",
"criterion": "larynx cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "HPV ((human papillomavirus) negative oropharyngeal cancer",
"criterion": "HPV status in oropharyngeal cancer",
"requirements": [
{
"requirement_type": "status",
"expected_value": "negative"
}
]
}
]
},
{
"line": "Patients planned for standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with nimorazole hypoxic cell radiosensitizer)",
"criterions": [
{
"exact_snippets": "standard curative treatment (radical radiotherapy with or without concomitant chemotherapy, with nimorazole hypoxic cell radiosensitizer)",
"criterion": "planned treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": [
"radical radiotherapy",
"concomitant chemotherapy",
"nimorazole hypoxic cell radiosensitizer"
]
}
]
}
]
},
{
"line": "Planned treatment at the Oslo University Hospital",
"criterions": [
{
"exact_snippets": "Planned treatment at the Oslo University Hospital",
"criterion": "treatment location",
"requirements": [
{
"requirement_type": "location",
"expected_value": "Oslo University Hospital"
}
]
}
]
},
{
"line": "Age > 18 years",
"criterions": [
{
"exact_snippets": "Age > 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "WHO (World Health Organization) performance status 0-2",
"criterions": [
{
"exact_snippets": "WHO (World Health Organization) performance status 0-2",
"criterion": "WHO performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"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": "TNM (primary tumor, regional nodes, metastasis) stage cT1 cN0-N1 cM0",
"criterions": [
{
"exact_snippets": "TNM (primary tumor, regional nodes, metastasis) stage cT1",
"criterion": "primary tumor stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "cT1"
}
]
},
{
"exact_snippets": "TNM (primary tumor, regional nodes, metastasis) stage ... cN0-N1",
"criterion": "regional nodes stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N"
},
{
"operator": "<=",
"value": 1,
"unit": "N"
}
]
}
}
]
},
{
"exact_snippets": "TNM (primary tumor, regional nodes, metastasis) stage ... cM0",
"criterion": "metastasis stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "cM0"
}
]
}
]
},
{
"line": "Glottic cancer cT1-T2 cN0 cM0",
"criterions": [
{
"exact_snippets": "Glottic cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "glottic"
}
]
},
{
"exact_snippets": "cT1-T2",
"criterion": "tumor stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "T"
},
{
"operator": "<=",
"value": 2,
"unit": "T"
}
]
}
}
]
},
{
"exact_snippets": "cN0",
"criterion": "lymph node involvement",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "0"
}
]
},
{
"exact_snippets": "cM0",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "0"
}
]
}
]
},
{
"line": "HPV positive oropharyngeal carcinoma",
"criterions": [
{
"exact_snippets": "HPV positive",
"criterion": "HPV status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "oropharyngeal carcinoma",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "oropharyngeal carcinoma"
}
]
}
]
},
{
"line": "Cancer in the soft palate",
"criterions": [
{
"exact_snippets": "Cancer in the soft palate",
"criterion": "cancer",
"requirements": [
{
"requirement_type": "location",
"expected_value": "soft palate"
}
]
}
]
},
{
"line": "Diabetes mellitus",
"criterions": [
{
"exact_snippets": "Diabetes mellitus",
"criterion": "diabetes mellitus",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}