This randomized trial evaluates a multimodal surveillance strategy in nasopharyngeal carcinoma patients with high-risk N3 cervical lymph node involvement after radiotherapy. Patients are assigned to standard follow-up or an enhanced strategy using CEUS, imaging, and EBV DNA for risk assessment. The intervention group uses multimodal evaluation to identify high-risk patients who may undergo multidisciplinary review and selective neck dissection when indicated. The primary endpoint is failure-free survival (FFS). Secondary endpoints include OS, LRRFS, DMFS, and safety .
Aged 18 to 70 years.
Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
Tumor staged as TanyN3M0 according to the 9th Edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
ECOG performance status 0-1.
Ongoing receipt of other antitumor treatment or concurrent participation in another interventional clinical trial.
Pregnancy or breastfeeding.
Severe concomitant disease that may, in the investigator's judgment, pose an unacceptable risk or compromise study compliance, including severe cardiac disease, severe pulmonary dysfunction, significant renal disease, or severe psychiatric illness.
History of another invasive malignancy within 5 years before enrollment, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder tumors (Ta, Tis, or T1).
Parallel
Multimodal Evaluation-Guided Surveillance Strategy
Procedure/SurgeryParticipants underwent multimodal follow-up evaluation after radiotherapy. Endoscopic selective neck dissection was performed only in participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and with surgical indications.
Failure-free Survival
Failure-free survival (FFS) is defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
Overall Survival
Overall survival is defined as the time from randomization to death from any cause. Participants alive at the last follow-up will be censored.
Distant Metastasis-Free Survival
Distant metastasis-free survival is defined as the time from randomization to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
Locoregional Relapse-free Survival
Locoregional relapse-free survival (LRRFS) is defined as the time from randomization to the first occurrence of locoregional recurrence or death from any cause, whichever occurs first.
Incidence of Acute and Late Toxicity
Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
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Xuelei Ma MD
Lead sponsor
West China Hospital
Sponsor institution
West China Hospital of Stomatology
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
General Hospital of Western Theater Command, PLA
Collaborator
Yibin Second People's Hospital
Collaborator
Miyi County People's Hospital
Collaborator
Jintang First People's Hospital
Collaborator
Yilong County people's Hospital
Collaborator
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