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NCT07692906
Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for Post-Radiotherapy N3 Nasopharyngeal Carcinoma
Conditions: Nasopharyngeal Cancinoma (NPC)
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Xuelei Ma MD
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 .
Eligibility Criteria
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).
Source: ClinicalTrials.gov (NCT07692906). StuddyBuddy aggregates publicly available trial information.