A Multicenter, Prospective, Phase III Clinical Study of Proton Intensity-modulated Radiotherapy Versus Photon Intensity-modulated Radiotherapy for Untreated Non-metastatic Nasopharyngeal Carcinoma

Proton therapy for nasopharyngeal carcinoma can reduce radiotherapy-related toxic reactions, and some retrospective studies have found that proton therapy improves the survival of patients with nasopharyngeal carcinoma. However, high-level prospective clinical evidence is still lacking. This study aims to investigate the efficacy and side effects of proton therapy compared with photon intensity-modulated radiotherapy for nasopharyngeal carcinoma through a multicenter, prospective, phase III clinical trial, providing more high-quality evidence-based medical evidence for proton therapy of nasopharyngeal carcinoma.

Inclusion Criteria: 1. Diagnosed by histology and/or cytology as non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, i.e., WHO type II or III). 2. Clinical stage: T1-4N0-3M0, I-III stage (AJCC 9th edition). 3. Age: ≥ 18 years old, ≤ 70 years old. 4. Gender: No restrictions. 5. ECOG ≤ 1. 6. Good organ function: Normal bone marrow function: WBC ≥ 4×109/L, Platelet ≥ 100×109/L, HGB ≥ 90g/L Total bilirubin, AST, ALT ≤ 2.0× upper limit of normal value; Creatinine clearance rate ≥ 60ml/min or Creatinine ≤ 1.5× upper limit of normal value. 7. The patient has signed the informed consent form and is willing and able to comply with the study visit schedule, treatment plan, laboratory tests and other research procedures. Exclusion Criteria: 1. The patient has a poor general condition and is in a state of poor health; or the patient has already experienced metastasis. 2. The patient has an uncontrolled severe infectious disease. 3. The patient has severe diseases or complications in the heart, lungs, liver, kidneys or other systems, and the investigator judges that they cannot complete the clinical trial. 4. There are implants such as artificial ears or dentures within the radiotherapy range, and the investigator judges that they are not suitable for proton therapy. 5. The patient has a history of radiotherapy in the head and neck region. 6. The patient has mental illness, drug abuse or alcohol dependence.