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OncoMatch/Clinical Trials/NCT04448522

Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma

Is NCT04448522 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for nasopharyngeal carcinoma.

Phase 3RecruitingSun Yat-sen UniversityNCT04448522Data as of May 2026

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: EBV DNA undetectable (0 copies/mL after 3 cycles of GP induction chemotherapy)

EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy

Disease stage

Required: Stage T1-3N1-2M0, T2-3N0M0, STAGE II-III (8th AJCC edition)

Excluded: Stage IV

Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition)

Prior therapy

Must have received: GP induction chemotherapy — induction

Evaluated as PR or CR after 3 cycles of GP induction chemotherapy

Cannot have received: chemotherapy or surgery

Exception: except diagnostic purpose

Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose)

Lab requirements

Blood counts

normal bone marrow function

Kidney function

creatinine clearance rate of at least 60 ml/min or creatinine of no more than 1.5 times the upper normal limit

Liver function

total bilirubin, ast and alt levels of no more than 2.5 times the upper normal limit

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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