RecruitingNot ApplicableNCT07412314

Proton Therapy for Recurrent Nasopharyngeal Carcinoma

A Prospective Phase II Clinical Study of Proton Therapy for Recurrent Nasopharyngeal Carcinoma

Sponsor

Guangzhou Concord Cancer Center

Enrollment

52 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent Nasopharyngeal Carcinoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.

Exclusion Criteria4

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

Interventions

RADIATIONProton therapy

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.

DEVICEProton radiation therapy

Radiation: Proton Therapy System (ProBeam)