Application of Endoscopic Selective Neck Dissection Under Multimodal Assessment for Residual Cervical Lymph Nodes in N3 Nasopharyngeal Carcinoma After Radiotherapy

NCT07636499 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: WCHSIRB-CT-2022-267-R1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase I clinical trial is to learn whether a multimodal follow-up evaluation combined with endoscopic selective neck dissection (ESND) is safe and feasible in patients with newly diagnosed N3 nasopharyngeal carcinoma. The main questions it aims to answer are:

• Is the multimodal evaluation-guided surveillance-intervention approach safe for patients?
• Is this approach feasible for identifying and managing residual cervical lymph nodes after radiotherapy? Participants will receive standard chemoradiotherapy. After treatment, they will undergo follow-up evaluation using clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with clinically suspicious residual cervical lymph nodes identified by multimodal evaluation and eligible for surgery underwent endoscopic selective neck dissection.

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Treatment-emergent adverse events are defined as adverse events occurring after the start of study intervention. Adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

  From enrollment through post-radiotherapy follow-up, up to 36 months

Secondary Outcomes (4)

• Completion Rate of Endoscopic Selective Neck Dissection Among Participants With Suspected Residual Cervical Nodal Disease

  From enrollment to completion of indicated endoscopic selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.

• Progression-Free Survival

  From enrollment to disease progression, death, or last follow-up, up to 36 months.

• Distant Metastasis-Free Survival

  From enrollment to distant metastasis, death, or last follow-up, up to 36 months.

• Overall Survival

  From enrollment to death or last follow-up, up to 36 months.

Study Arms (1)

Multimodal Evaluation-Guided Surveillance-Intervention Strategy

EXPERIMENTAL

Participants underwent multimodal follow-up evaluation after radiotherapy, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and suitable for surgery underwent endoscopic selective neck dissection.

Procedure: Multimodal Evaluation-Guided Surveillance-Intervention Strategy

Interventions

Multimodal Evaluation-Guided Surveillance-Intervention Strategy PROCEDURE

All participants 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.

Multimodal Evaluation-Guided Surveillance-Intervention Strategy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 8th Edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
• ECOG performance status 0-1.
• No previous neck dissection.
• Adequate hematologic, hepatic, and renal function, defined as: white blood cell count ≥4.0 × 10\^9/L, absolute neutrophil count ≥2.0 × 10\^9/L, hemoglobin ≥90 g/L, platelet count ≥100 × 10\^9/L, aspartate aminotransferase and alanine aminotransferase ≤2.5 × the upper limit of normal, and creatinine clearance ≥60 mL/min
• Written informed consent provided prior to study enrollment

You may not qualify if:

• 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).

Sponsors & Collaborators

• Guiquan Zhu: lead

Study Sites (1)

West China Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 9, 2026
• Study Start: August 30, 2022
• Primary Completion: August 30, 2025
• Study Completion: June 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)