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

Condition(s) studied

Investigational drug(s) / intervention(s)

Proton Therapy System (ProBeam): Treatment 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): Treatment 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 3-year progression-free survival time — From enrollment to the three-year follow-up period
  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 — during radiotherapy
  Grade III or higher oral mucositis occurring during radiotherapy

Trial sites (2)

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