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

A Phase 1 Trial of Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for N3 Nasopharyngeal Carcinoma After Radiotherapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasopharyngeal Cancinoma (NPC)
• Intervention / Treatment: Procedure: Multimodal Evaluation-Guided Surveillance-Intervention Strategy

Detailed Description

Patients with N3 nasopharyngeal carcinoma remain at risk of residual cervical lymph nodes after radiotherapy. Conventional imaging may have difficulty distinguishing viable residual tumor from post-radiotherapy edema, fibrosis, scarring, or inflammation. Contrast-enhanced ultrasound (CEUS) provides information on lymph node microvascular perfusion and may complement routine follow-up assessment. For patients with suspected residual cervical lymph nodes, neck dissection is an established salvage treatment option. Endoscopic selective neck dissection (ESND) is a minimally invasive surgical approach based on the principles of selective neck dissection and may reduce surgical trauma. This prospective, single-center, single-arm phase I study enrolled patients with pathologically confirmed N3 nasopharyngeal carcinoma. After completion of radiotherapy, participants underwent multimodal cervical lymph node follow-up evaluation, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and CEUS. During follow-up, participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and suitable for surgery underwent ESND. Participants were followed for adverse events, postoperative complications, disease progression, locoregional recurrence, distant metastasis, and survival outcomes. The main purpose of this study is to evaluate the safety and feasibility of this multimodal evaluation-guided surveillance-intervention strategy.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Stomatology, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 to 70 years.
2. Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
3. 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.
4. ECOG performance status 0-1.
5. No previous neck dissection.
6. 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
7. Written informed consent provided prior to study enrollment

Exclusion Criteria:

1. Ongoing receipt of other antitumor treatment or concurrent participation in another interventional clinical trial.
2. Pregnancy or breastfeeding
3. 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.
4. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multimodal Evaluation-Guided Surveillance-Intervention Strategy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rate of Endoscopic Selective Neck Dissection Among Participants With Suspected Residual Cervical Nodal Disease	The completion rate is defined as the proportion of participants who undergo endoscopic selective neck dissection as planned among participants with suspected residual cervical nodal disease identified by multimodal evaluation.	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	Progression-free survival is defined as the time from enrollment to disease progression, recurrence, distant metastasis, or death from any cause, whichever occurs first.	From enrollment to disease progression, death, or last follow-up, up to 36 months.
Distant Metastasis-Free Survival	Distant metastasis-free survival is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.	From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
Overall Survival	Overall survival is defined as the time from enrollment to death from any cause. Participants alive at the last follow-up will be censored.	From enrollment to death or last follow-up, up to 36 months.

Collaborators and Investigators

• Sponsor: Guiquan Zhu

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): August 30, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: WCHSIRB-CT-2022-267-R1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Complete de-identified patient data set will be submitted onto an online platform.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No