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
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients with N3 nasopharyngeal carcinoma remain at risk of residual cervical lymph node disease 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 node disease, selective neck dissection may be considered as a salvage treatment option.
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 considered suitable for surgical intervention underwent selective neck dissection. 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital of Stomatology, Sichuan University
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Aged 18 to 70 years.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
- 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.
- ECOG performance status 0-1.
- No previous neck dissection.
- 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
- Written informed consent provided prior to study enrollment
Exclusion Criteria:
- Ongoing receipt of other antitumor treatment or concurrent participation in another interventional clinical trial.
- Pregnancy or breastfeeding
- 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.
- 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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 considered suitable for surgical intervention underwent selective neck dissection.
|
All participants underwent multimodal follow-up evaluation after radiotherapy.
Selective neck dissection was performed only in participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered to have an indication for surgical intervention.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events
Tidsramme: From enrollment through post-radiotherapy follow-up, up to 36 months
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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.
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From enrollment through post-radiotherapy follow-up, up to 36 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
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From enrollment to disease progression, death, or last follow-up, up to 36 months.
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Distant Metastasis-Free Survival
Tidsramme: From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
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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.
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From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
|
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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.
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From enrollment to death or last follow-up, up to 36 months.
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Completion Rate of Selective Neck Dissection Among Participants With Suspected Residual Cervical Nodal Disease
Tidsramme: From enrollment to completion of indicated selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
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The completion rate is defined as the proportion of participants who undergo selective neck dissection as planned among participants with suspected residual cervical nodal disease identified by multimodal evaluation.
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From enrollment to completion of indicated selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- WCHSIRB-CT-2022-267-R1
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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