Head and neck malignant tumors
Conditions
Interventions
Training set:None
Observational validation cohort:None
External test set:None
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age > 18 years; 2.Histopathologically confirmed head and neck malignant tumor; 3.Planned to receive radiotherapy or radiotherapy combined with systemic therapy (chemotherapy, targeted therapy, immunotherapy); 4.ECOG performance status 0–1; 5.No contraindications to chemotherapy, targeted therapy, immunotherapy, or radiotherapy; 6.Female patients of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days before enrollment, and be willing to use effective contraception during the study period. Male patients with partners of childbearing potential should use effective contraception during the study period; 7.Complete baseline clinical data, CT imaging data, biomarker data, and radiotherapy dosimetry data available; 8.Clear follow-up records of oral mucositis covering at least 60 days after the start of radiotherapy; 9.Clear documentation of medication strategy (prophylactic or therapeutic);
Exclusion criteria
Exclusion criteria: 1.Prior or concurrent other untreated malignant tumors, with the exception of cured head and neck malignancies; 2.Presence of any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [patients can be included if thyroid function returns to normal after hormone replacement therapy]). Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthmatic patients requiring bronchodilators for medical intervention are excluded. 3.Uncontrolled cardiovascular disease: grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval = 470 ms); New York Heart Association (NYHA) class III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 50% on echocardiography; myocardial infarction within the past year; 4.Deemed unsuitable for radiotherapy by the treating physician; 5.Participation in another clinical study within 4 weeks before the first radiotherapy (for patients already in follow-up, the calculation is based on the last use of the investigational drug or device), or currently participating in another clinical study; 6.Pregnant or breastfeeding women; 7.Any other condition that, in the investigator's judgment, may force the subject to terminate the study prematurely, such as other serious diseases (including psychiatric disorders) requiring concurrent treatment, severely abnormal laboratory values, or family or social factors that may affect subject safety or study data collection; 8.Presence of severe oral mucositis before radiotherapy; 9.Excessive missing data for key predictor variables;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe oral mucositis (SOM) and predictive performance of the model; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to SOM occurrence, incidence of early SOM, model stability across different datasets;Risk stratification based on the prediction model and exploration of individualized treatment strategies; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The First Affiliated Hospital of China Medical University
Outcome results
None listed