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

NCT07578727 | Not Yet Recruiting DMC

• 1 other identifier: 2026-IIT-003
• Study Type: interventional
• Target: 504
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

proton therapy; nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the three-year follow-up period

Secondary Outcomes (5)

• Overall survival time

  From enrollment to the three-year follow-up period

• Distance-free metastasis-free survival time (DMFS)

  From enrollment to the three-year follow-up period

• No local region recurrence-free survival time (LRFS)

  From enrollment to the three-year follow-up period

• Incidence of severe late complications

  From enrollment to the three-year follow-up period

• Short-term treatment responses

  From enrollment to the three-month follow-up period

Study Arms (2)

Proton therapy group

EXPERIMENTAL

All patients received proton therapy, with a prescribed dose of 70Gy in 33 fractions, 5 days per week, for a total of 6.5 weeks.

Radiation: Proton Therapy System (ProBeam)

Photon therapy group

PLACEBO COMPARATOR

All patients received photon therapy, with a prescribed dose of 70Gy in 33 fractions, 5 days per week, for a total of 6.5 weeks.

Radiation: Photon Therapy System (TrueBeam)

Interventions

Photon Therapy System (TrueBeam) RADIATION

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.

Photon therapy group

Proton Therapy System (ProBeam) RADIATION

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.

Proton therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Gender Eligibility Description:
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG ≤ 1.
• 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.
• 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.

You may not qualify if:

• 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.
• The patient has a history of radiotherapy in the head and neck region.
• The patient has mental illness, drug abuse or alcohol dependence.

Sponsors & Collaborators

• Guangzhou Concord Cancer Center: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Taize Yuan

CONTACT

8620-32506195; taize.yuan@ccm.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share