Nasopharyngeal Cancinoma (NPC)
Conditions
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 .
Detailed description
This is a multicenter, randomized controlled clinical trial evaluating a multimodal evaluation-guided surveillance and intervention strategy in patients with nasopharyngeal carcinoma (NPC) with high-risk N3-stage cervical lymph node involvement after radiotherapy. The study investigates whether combining contrast-enhanced ultrasound (CEUS), conventional imaging (CT/MRI), and Epstein-Barr virus (EBV) DNA monitoring can improve risk stratification, early detection of residual disease, and optimize subsequent treatment decision-making. Eligible patients will be randomly assigned in a 1:1 ratio to receive either standard post-radiotherapy follow-up or a multimodal evaluation-guided surveillance and intervention strategy. In the control group, patients will receive standard follow-up care according to clinical guidelines. No CEUS or structured multimodal risk stratification will be applied in this group. In the intervention group, patients will undergo an enhanced follow-up strategy based on multimodal evaluation, which integrates CEUS, conventional imaging, and EBV DNA to stratify the risk of residual lymph node disease. Patients identified as high/ very high-risk may receive further multidisciplinary evaluation, and endoscopic selective neck dissection will be performed when indicated. The primary endpoint is failure-free survival (FFS), defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first. Secondary endpoints include overall survival (OS), locoregional relapse-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related safety. Safety will be evaluated according to CTCAE version 5.0. A total of 80 patients will be enrolled across multiple centers in China.
Interventions
PROCEDUREMultimodal Evaluation-Guided Surveillance Strategy
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.
Sponsors
Xuelei Ma MD
West China Hospital of Stomatology
Sichuan Cancer Hospital and Research Institute
General Hospital of Western Theater Command, PLA
Yibin Second People's Hospital
Miyi County People's Hospital
Jintang First People's Hospital
Yilong County people's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free Survival | From randomization to disease failure, death, or last follow-up, up to 60 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From randomization to death or last follow-up, up to 60 months | Overall survival is defined as the time from randomization to death from any cause. Participants alive at the last follow-up will be censored. |
| Distant Metastasis-Free Survival | From randomization to distant metastasis, death, or last follow-up, up to 60 months | Distant metastasis-free survival is defined as the time from randomization to the first occurrence of distant metastasis or death from any cause, whichever occurs first. |
| Locoregional Relapse-free Survival | From randomization to locoregional recurrence, death, or last follow-up, up to 60 months. | Locoregional relapse-free survival (LRRFS) is defined as the time from randomization to the first occurrence of locoregional recurrence or death from any cause, whichever occurs first. |
| Incidence of Acute and Late Toxicity | From randomization to locoregional recurrence, death, or last follow-up, up to 60 months. | Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. |
Outcome results
None listed