About this trial
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 .
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Multimodal Evaluation-Guided Surveillance Strategy
Treatment groups
Locations
Sponsors and collaborators
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