Clinical trial · Interventional
Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for Post-Radiotherapy N3 Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Cancinoma (NPC) | Nasopharyngeal Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Evaluation-Guided Surveillance Strategy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multimodal Evaluation-Guided Surveillance-Intervention Strategy
- description
- 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.
- interventionNames
- Procedure: Multimodal Evaluation-Guided Surveillance Strategy
- type
- NO_INTERVENTION
- label
- Standard follow-up strategy
- description
- Patients will receive standard follow-up care according to clinical guidelines. No CEUS or structured multimodal risk stratification will be applied in this group.
Primary outcomes (1)
- measure
- Failure-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 9th 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).
References
Publications (0)
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