Individualized neck irradiation for nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, randomized, open‑label phase III non‑inferiority trial enrolling 462 patients with newly diagnosed, non‑metastatic nasopharyngeal carcinoma (T1‑4N0‑3M0). Patients are randomized to an individualized neck irradiation arm—where prophylactic coverage extends to 3 cm below the lowest involved or suspected lymph node—versus a standard bilateral upper‑plus‑lower neck prophylactic irradiation arm. Radiotherapy planning follows the 2024 international contouring guidelines and stratifies by photon IMRT alone versus photon IMRT combined with carbon‑ion radiotherapy, with prescribed dose levels specified for gross tumor and elective volumes. The planned accrual is three years with three years of post‑treatment follow‑up to compare regional control and safety between arms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Proton and Heavy Ion Center
  Shanghai, China Recruiting
• Eye, Ear, Nose and Throat Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Not yet recruiting
• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Not yet recruiting
• Sichuan Cancer Hospital & Institute
  Chengdu, China Not yet recruiting
• Chongqing Cancer Hospital
  Chongqing, China Not yet recruiting

Study contacts

• Study coordinator: Xiyin Guan, MD. PhD.
• Email: forrestguan@163.com
• Phone: +86-15921292432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.