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Application of Endoscopic Selective Neck Dissection Under Multimodal Assessment for Residual Cervical Lymph Nodes in N3 Nasopharyngeal Carcinoma After Radiotherapy

2. juni 2026 opdateret af: Guiquan Zhu

A Phase 1 Trial of Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for N3 Nasopharyngeal Carcinoma After Radiotherapy

The goal of this phase I clinical trial is to learn whether a multimodal follow-up evaluation combined with endoscopic selective neck dissection (ESND) is safe and feasible 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 will receive standard chemoradiotherapy. After treatment, they will undergo follow-up evaluation using clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with clinically suspicious residual cervical lymph nodes identified by multimodal evaluation and eligible for surgery underwent endoscopic selective neck dissection.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients with N3 nasopharyngeal carcinoma remain at risk of residual cervical lymph nodes after radiotherapy. Conventional imaging may have difficulty distinguishing viable residual tumor from post-radiotherapy edema, fibrosis, scarring, or inflammation. Contrast-enhanced ultrasound (CEUS) provides information on lymph node microvascular perfusion and may complement routine follow-up assessment. For patients with suspected residual cervical lymph nodes, neck dissection is an established salvage treatment option. Endoscopic selective neck dissection (ESND) is a minimally invasive surgical approach based on the principles of selective neck dissection and may reduce surgical trauma. This prospective, single-center, single-arm phase I study enrolled patients with pathologically confirmed N3 nasopharyngeal carcinoma. After completion of radiotherapy, participants underwent multimodal cervical lymph node follow-up evaluation, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and CEUS. During follow-up, participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and suitable for surgery underwent ESND. Participants were followed for adverse events, postoperative complications, disease progression, locoregional recurrence, distant metastasis, and survival outcomes. The main purpose of this study is to evaluate the safety and feasibility of this multimodal evaluation-guided surveillance-intervention strategy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital of Stomatology, Sichuan University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Multimodal Evaluation-Guided Surveillance-Intervention Strategy
All 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Treatment-Emergent Adverse Events
Tidsramme: From enrollment through post-radiotherapy follow-up, up to 36 months
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.
From enrollment through post-radiotherapy follow-up, up to 36 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Completion Rate of Endoscopic Selective Neck Dissection Among Participants With Suspected Residual Cervical Nodal Disease
Tidsramme: From enrollment to completion of indicated endoscopic selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
The completion rate is defined as the proportion of participants who undergo endoscopic selective neck dissection as planned among participants with suspected residual cervical nodal disease identified by multimodal evaluation.
From enrollment to completion of indicated endoscopic selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
Progression-Free Survival
Tidsramme: From enrollment to disease progression, death, or last follow-up, up to 36 months.
Progression-free survival is defined as the time from enrollment to disease progression, recurrence, distant metastasis, or death from any cause, whichever occurs first.
From enrollment to disease progression, death, or last follow-up, up to 36 months.
Distant Metastasis-Free Survival
Tidsramme: From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
Distant metastasis-free survival is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
Overall Survival
Tidsramme: From enrollment to death or last follow-up, up to 36 months.
Overall survival is defined as the time from enrollment to death from any cause. Participants alive at the last follow-up will be censored.
From enrollment to death or last follow-up, up to 36 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Guiquan Zhu

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. august 2022

Primær færdiggørelse (Faktiske)

30. august 2025

Studieafslutning (Anslået)

1. juni 2026

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • WCHSIRB-CT-2022-267-R1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Complete de-identified patient data set will be submitted onto an online platform.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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