Clinical trial · Interventional
Selective Neck Dissection Under Multimodal Assessment for N3 Nasopharyngeal Carcinoma After Radiotherapy
A Phase 1 Trial of Multimodal Evaluation-Guided Surveillance-Intervention With Selective Neck Dissection for N3 Nasopharyngeal Carcinoma After Radiotherapy
- 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)
The goal of this phase I clinical trial is to evaluate the safety and feasibility of a multimodal evaluation-guided surveillance-intervention strategy 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 receive standard chemoradiotherapy. After treatment, they undergo follow-up evaluation using 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 considered suitable for surgical intervention undergo selective neck dissection.
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-Intervention Strategy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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 considered suitable for surgical intervention underwent selective neck dissection.
- interventionNames
- Procedure: Multimodal Evaluation-Guided Surveillance-Intervention Strategy
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- From enrollment through post-radiotherapy follow-up, up to 36 months
- description
- 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.
Secondary outcomes (4)
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 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).
References
Publications (0)
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