Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for Post-Radiotherapy N3 Nasopharyngeal Carcinoma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuelei Ma MD

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

80 Participants
are divided into 2 treatment groups

Locations

This trial has no 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