Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for Post-Radiotherapy N3 Nasopharyngeal Carcinoma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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 9th 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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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.
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Sem intervenção: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Failure-free Survival
Prazo: From randomization to disease failure, death, or last follow-up, up to 60 months.
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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.
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From randomization to disease failure, death, or last follow-up, up to 60 months.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall Survival
Prazo: From randomization to death or last follow-up, up to 60 months
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Overall survival is defined as the time from randomization to death from any cause.
Participants alive at the last follow-up will be censored.
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From randomization to death or last follow-up, up to 60 months
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Distant Metastasis-Free Survival
Prazo: From randomization to distant metastasis, death, or last follow-up, up to 60 months
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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.
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From randomization to distant metastasis, death, or last follow-up, up to 60 months
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Locoregional Relapse-free Survival
Prazo: From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
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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.
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From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
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Incidence of Acute and Late Toxicity
Prazo: From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
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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.
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From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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