Proton Therapy for Recurrent Nasopharyngeal Carcinoma

NCT07412314 | Recruiting DMC

• 1 other identifier: 2024-IIT-007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

The above studies show that most of the supportive evidence for the reduction of toxicity and improvement of efficacy of proton therapy for recurrent Nasopharyngeal carcinoma(NPC) comes from various observational and retrospective studies, lacking high-level evidence-based medical evidence. The conduct of this study will explore the safety and efficacy of intensity-modulated proton radiotherapy for recurrent NPC and provide more high-quality evidence-based medical evidence for proton therapy of recurrent cancer.

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

proton therapy; recurrent nasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the three-year follow-up period

Secondary Outcomes (3)

• Overall survival time

  From enrollment to the three-year follow-up period

• Local progression-free survival time

  From enrollment to the three-year follow-up period

• Short-term treatment responses

  From enrollment to the three-month follow-up period

Study Arms (1)

Proton therapy group

EXPERIMENTAL

All patients received proton therapy, with a prescribed dose of 60-66 Gy in 30-33 fractions, 5 days per week, for a total of 6-6.5 weeks.

Radiation: Proton therapy; Device: Proton radiation therapy

Interventions

Proton therapy 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. The CTV was defined as an expansion of 5-10mm outside the GTV. Radiation dose and treatment plan: The prescribed dose was 60-66 Gray (Gy) delivered in 30-33 fractions. Plan design and dose verification: The physicist designed radiotherapy plans according to the requirements of the physician. 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

Proton radiation therapy DEVICE

Radiation: Proton Therapy System (ProBeam)

Proton therapy group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-metastatic squamous cell carcinoma of the nasopharynx with biopsy confirmation, at stage ≥ T2b and/or with positive lymph nodes, (2) Pathological type WHO I-III
• PS score (according to Eastern Cooperative Oncology Group (ECOG) standard) 0-1.
• Age ≥ 18 years.
• Expected survival period ≥ 6 months
• Before treatment, evaluate the tumor range and size of the patient.
• Nutritional and general physical condition must be able to tolerate the recommended radiotherapy and chemotherapy.

You may not qualify if:

• Evidence of distant metastasis in stage IVc
• Patients with isolated recurrence of cervical lymph nodes;
• Patients have participated in other interventional trials for tumors
• Having suffered from other malignant tumors within 5 years (excluding melanoma skin cancer) or tumors originating from the head and neck region Untreated active infections

Sponsors & Collaborators

• Guangzhou Concord Cancer Center: lead

Study Sites (2)

Guangzhou Concord Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Guangzhou concord cancer center

Guanzhou, Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Proton Therapy

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

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Yuan Taize

  private hospital

  STUDY DIRECTOR

Central Study Contacts

Taize Yuan, M.D., Ph.D.

CONTACT

8620-32506195; taize.yuan@ccm.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 10, 2025
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): March 10, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-02

Locations

CN (2)