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

NCT07692906 | Not Yet Recruiting DMC

• 1 other identifier: 2026 (1385)
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization to disease failure, death, or last follow-up, up to 60 months.

Secondary Outcomes (4)

• Overall Survival

  From randomization to death or last follow-up, up to 60 months

• Distant Metastasis-Free Survival

  From randomization to distant metastasis, death, or last follow-up, up to 60 months

• Locoregional Relapse-free Survival

  From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.

• Incidence of Acute and Late Toxicity

  From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.

Study Arms (2)

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 Strategy

Standard follow-up strategy

NO INTERVENTION

Patients will receive standard follow-up care according to clinical guidelines. No CEUS or structured multimodal risk stratification will be applied in this group.

Interventions

Multimodal Evaluation-Guided Surveillance Strategy PROCEDURE

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 9th 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

• Sichuan Cancer Hospital and Research Institute: collaborator
• Yibin Second People's Hospital: collaborator
• Yilong County people's Hospital: collaborator
• Xuelei Ma MD: lead
• West China Hospital of Stomatology: collaborator
• General Hospital of Western Theater Command, PLA: collaborator
• Miyi County People's Hospital: collaborator
• Jintang First People's Hospital: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 30, 2035
• Study Completion (Estimated): June 30, 2035
• Last Updated: July 9, 2026

Record last verified: 2026-06