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

3 luglio 2026 aggiornato da: Xuelei Ma MD
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 .

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Multimodal Evaluation-Guided Surveillance-Intervention Strategy
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.
Procedura: Multimodal 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.
Nessun intervento: Standard follow-up strategy
Patients will receive standard follow-up care according to clinical guidelines. No CEUS or structured multimodal risk stratification will be applied in this group.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Failure-free Survival
Lasso di tempo: 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.
From randomization to disease failure, death, or last follow-up, up to 60 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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.
From randomization to death or last follow-up, up to 60 months
Distant Metastasis-Free Survival
Lasso di tempo: 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.
From randomization to distant metastasis, death, or last follow-up, up to 60 months
Locoregional Relapse-free Survival
Lasso di tempo: 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.
From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
Incidence of Acute and Late Toxicity
Lasso di tempo: 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.
From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Xuelei Ma MD

Collaboratori

Sichuan Cancer Hospital and Research Institute
Yilong County people's Hospital
West China Hospital of Stomatology
General Hospital of Western Theater Command, PLA
Yibin Second People's Hospital
Miyi County People's Hospital
Jintang First People's Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 giugno 2035

Completamento dello studio (Stimato)

30 giugno 2035

Date di iscrizione allo studio

Primo inviato

3 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2026 (1385)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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