Individualized Neck Cervical Irradiation Prophylaxis Trial of NPC

NCT07303023 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Phase 3

Started

2025-09-01

Last updated

2025-12-24

Condition(s) studied

Nasopharyngeal Carcinoma (NPC)

Investigational drug(s) / intervention(s)

Individualized Neck IrradiationStandard Neck Irradiation

Individualized Neck Irradiation: After confirmation of the radiotherapy technique, patients will be randomized. Patients in the investigational arm will receive bilateral upper neck irradiation covering at least Level II. If cervical lymph nodes are positive, the clinical target volume (CTV) will extend to 3 cm below the lowest level of metastatic (including suspected) lymph nodes.

Standard Neck Irradiation: Patients in the control arm will receive bilateral upper neck irradiation to level III; if upper neck nodes are positive, prophylactic irradiation of the lower neck will be performed.

Study summary

Based on the pattern of nasopharyngeal carcinoma cervical lymph node metastasis, which typically follows a sequential downward spread with rare skip metastases and a tendency for ipsilateral neck involvement, and in accordance with the latest international guidelines, we propose the following scientific hypothesis: individualized neck prophylactic irradiation for nasopharyngeal carcinoma based on the superior-to-inferior extent of metastatic lymph nodes is feasible. Specifically: if there is no lymph node metastasis, irradiation need only extend to the lower border of Level II; if there are suspected metastatic lymph nodes, a prophylactic dose of 55-60 Gy should be administered; the investigational arm will only require irradiation extending to 3 cm below the lowest level of metastatic (including suspected) lymph nodes in each neck.This study will prospectively enroll patients with N0-N3 stage nasopharyngeal carcinoma and randomize them to compare individualized neck irradiation based on the vertebral body level of metastatic lymph nodes versus selective upper neck prophylactic irradiation. The primary endpoint is neck recurrence-free survival. Secondary endpoints include overall survival, local recurrence-free survival and other survival data, incidence of acute and late neck radiation-induced injuries, and quality of life, aiming to validate the feasibility of individualized neck irradiation based on metastatic patterns.Photon IMRT and photon plus carbon-ion radiotherapy will serve as stratification factors, enabling further comparison of local control and toxicity between photon-carbon-ion therapy and photon-only (or proton) therapy. This study seeks to protect critical structures such as the thyroid, trachea, esophagus, and neck muscles while maintaining therapeutic efficacy, ultimately improving the quality of life for nasopharyngeal carcinoma patients.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. Age 18-70 years. 2. Pathologically confirmed WHO type I, II, or III nasopharyngeal carcinoma. 3. Staged as T1-4N0-3 M0, Stage I-III according to the UICC/AJCC 9th edition staging system. 4. Absence of distant metastasis confirmed by systemic FDG PET/CT (or whole-body bone scan plus chest CT and abdominal ultrasound). 5. Ability to undergo MRI examination. 6. Adequate major organ function meeting radiotherapy requirements: 1. Hematopoietic function: Hemoglobin ≥9 g/L, Platelets ≥100×10⁹/L, WBC ≥3.5×10⁹/L, Neutrophils ≥2.0×10⁹/L. 2. Liver function: ALT and AST \< 2.5 × ULN, Bilirubin \< 1.5 × ULN. 3. Renal function: Creatinine clearance ≥50 mL/min or serum creatinine within normal range. 4. Patients with clinical symptoms will be evaluated based on specific manifestations. 7. ECOG performance status 0-1; absence of severe comorbidities (e.g., severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease) that may preclude radiotherapy. Cardiac function class 1-2 (NYHA classification). 8. Life expectancy ≥12 months. 9. Patients must be informed of the study details and provide written informed consent. Exclusion Criteria: 1. Pathology not confirming WHO type I, II, or III nasopharyngeal carcinoma. 2. Distant metastasis identified clinically or radiologically before treatment, or presence of skip metastases in cervical lymph nodes. 3. Pregnancy (confirmed by serum or urine β-HCG test) or lactation. 4. Unwillingness to provide informed consent. 5. Prior radiotherapy to the head and neck region. 6. Comorbidities or other factors that may contraindicate photon or carbon-ion therapy. 7. Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons. 8. Known allergy to chemotherapeutic agents (e.g., cisplatin, docetaxel, gemcitabine) or contrast media used in the study's imaging examinations. 9. Contraindication to contrast-enhanced MRI. 10. Major organ dysfunction, or severe uncontrolled concurrent infection or medical illness (e.g., decompensated cardiac, pulmonary, renal, or hepatic failure). 11. History of immunodeficiency (positive HIV test), other acquired/congenital immunodeficiency disorders, or history of organ/allogeneic bone marrow transplantation. 12. History of other malignancies prior to enrollment (except for basal cell carcinoma of the skin). 13. History of substance or alcohol abuse. 14. Any other condition deemed by the investigator to potentially lead to study discontinuation, including co-morbidities (including psychiatric) requiring concomitant treatment, severely abnormal laboratory values, or familial/social factors compromising patient safety or data integrity.

Primary outcome measure(s)

neck recurrence-free survival. — 3-year neck recurrence-free survival.

Trial sites (6)

Facility	City	Region	Status
Fudan University Shanghai Cancer Center	Shanghai	Shanghai Municipality	Recruiting
Eye, Ear, Nose and Throat Hospital of Fudan University	Shanghai	Shanghai Municipality	Not Yet Recruiting
Zhejiang Cancer Hospital	Hangzhou	Zhejiang	Not Yet Recruiting
Sichuan Cancer Hospital & Institute	Chengdu	China	Not Yet Recruiting
Chongqing Cancer Hospital	Chongqing	China	Not Yet Recruiting
Shanghai Proton and Heavy Ion Center	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303023 on ClinicalTrials.gov ↗ ← All trials in China