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

Plain Language Summary

Simplified for easier understanding

This study examines proton therapy — a precise form of radiation — for patients with nasopharyngeal carcinoma (cancer at the back of the nasal passage) that has come back after prior treatment, combining radiation with chemotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed squamous cell carcinoma of the nasopharynx that has recurred - Your cancer is at a sufficiently advanced stage locally (at least T2b and/or with affected lymph nodes) - Your cancer has not spread to distant organs (no distant metastases) - Your overall health is good (ECOG 0-1) and expected survival is at least 6 months - You are physically able to tolerate both radiation and chemotherapy **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (stage IVc) - You only have isolated lymph node recurrence in the neck without local recurrence - You have had another cancer within the past 5 years (except treated skin cancers) - You have participated in another interventional cancer trial - You have an untreated active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)