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.
Diagnosed by histology and/or cytology as non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, i.e., WHO type II or III).
Clinical stage: T1-4N0-3M0, I-III stage (AJCC 9th edition).
Age: ≥ 18 years old, ≤ 70 years old.
Gender: No restrictions.
The patient has a poor general condition and is in a state of poor health; or the patient has already experienced metastasis.
The patient has an uncontrolled severe infectious disease.
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.
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.
Parallel
Proton Therapy System (ProBeam)
RadiationTreatment planning and target delineation: All patients were in the supine position with the head extended backward, with the mask fixed, and enhanced computed tomography (CT) scans were performed for positioning. The slice thickness was 1.25mm. The gross tumor volume (GTV) included the recurrent primary lesion. The clinical target volume (CTV) included the anatomical expansion of the tumor and the suspicious lesions visible under the microscope. CTV specific delineation refers to the Chinese Nasopharyngeal Carcinoma Radiotherapy Guidelines (2022 edition).Radiation dose and treatment plan: The prescribed dose was 70 Gray (Gy) delivered in 33 fractions. Physicists design intensity-modulated proton therapy plans according to the physician's requirements. After the radiotherapy plan was designed, it was evaluated and repeatedly optimized by the physician and the physicist until satisfactory results were achieved. Treatment: was required for each treatment session.
Photon Therapy System (TrueBeam)
RadiationTreatment planning and target delineation: All patients were in the supine position with the head extended backward, with the mask fixed, and enhanced computed tomography (CT) scans were performed for positioning. The slice thickness was 1.25mm. The gross tumor volume (GTV) included the recurrent primary lesion. The clinical target volume (CTV) included the anatomical expansion of the tumor and the suspicious lesions visible under the microscope. CTV specific delineation refers to the Chinese Nasopharyngeal Carcinoma Radiotherapy Guidelines (2022 edition).Radiation dose and treatment plan: The prescribed dose was 70 Gray (Gy) delivered in 33 fractions. Physicists design intensity-modulated photon therapy plans according to the physician's requirements. After the radiotherapy plan was designed, it was evaluated and repeatedly optimized by the physician and the physicist until satisfactory results were achieved. Treatment: was required for each treatment session.
3-year progression-free survival time
Defined as the time interval from the start of treatment to tumor progression or death for any reason; if there is no tumor progression, it is until the time of the last follow-up.
Incidence of severe oral mucositis
Grade III or higher oral mucositis occurring during radiotherapy
Overall survival time
Defined as the time interval from the start of treatment to death from any cause; if no death occurs, it is until the date of the last follow-up.
Distance-free metastasis-free survival time (DMFS)
The definition is the time interval from the start of treatment to the occurrence of distant metastasis. If there is no distant metastasis, it is the time until the last follow-up.
No local region recurrence-free survival time (LRFS)
It is defined as the time interval from the start of treatment to the occurrence of local regional recurrence. If there is no local regional recurrence, it is the time until the last follow-up.
Incidence of severe late complications
The proportion of subjects whose toxicity reaction is level 3 during the clinical trial period. The researchers record AE that appeared during the clinical trial cycle and grade it according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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