Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure
20 de agosto de 2026 atualizado por: Second Affiliated Hospital, Zhejiang University, School of Medicine
Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure: A Prospective, Multicenter, Phase II Clinical Trial
There remains no uniform treatment modality for glottic laryngeal carcinoma.
Current clinical guidelines broadly recommend surgery or radiotherapy as single modality treatment for early stage glottic laryngeal carcinoma.
Glottic carcinoma with anterior commissure invasion is linked to inferior local control; both definitive radiotherapy alone or transoral laser microsurgery (TLM) may confer a higher risk of local recurrence compared with other glottic carcinomas.
We hypothesize that postoperative radiotherapy can act as an effective adjunct to surgery and reduce recurrence rates in patients with glottic carcinoma involving the anterior commissure.
This study aims to conduct a multicenter, prospective, single arm phase II clinical trial of intensity modulated radiotherapy (IMRT) for postoperative patients with early stage glottic laryngeal carcinoma and anterior commissure involvement, to preliminarily evaluate the effect of IMRT on local control rates and long term survival outcomes in this patient population.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
38
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Dongjun Dai, Doctor
- Número de telefone: 86-0571-86992821
- E-mail: daidongjunmed@zju.edu.cn
Locais de estudo
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Recrutamento
- Second Affiliated Hospital of Zhejiang University School of Medicine
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Aged 18 years or older, regardless of gender;
- Pathologically confirmed glottic squamous cell carcinoma;
- T1-T2N0M0 glottic laryngeal carcinoma with anterior commissure involvement;
- Patients who have undergone curative intent surgery for glottic carcinoma with negative surgical margins, within 4-8 weeks post operation;
- No prior radiotherapy, chemotherapy or other anti neoplastic agent treatment;
- ECOG performance status of 0 or 1;
- Signed informed consent form.
Exclusion Criteria:
- Patients without anterior commissure involvement;
- Prior chemotherapy or treatment with other anti neoplastic agents;
- Prior history of head and neck radiotherapy;
- Prior participation in other clinical trials;
- Patients with severe allergy history or allergic diathesis, e.g., contrast medium allergy;
- Pregnant or lactating women;
- Patients with uncontrolled acute infection;
- Patients with drug addiction, substance abuse, chronic heavy alcohol consumption, or human immunodeficiency virus (HIV) infection;
- Patients with other uncontrolled concurrent malignancies.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Postoperative radiotherapy
intensity modulated radiotherapy (IMRT)
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Postoperative radiotherapy clinical target volume (CTV) design: The conventional postoperative laryngeal radiotherapy target is defined as CTV1, which encompasses the entire laryngeal structure, piriform sinus, gloss-epiglottic vallecula, paraglottic space, pre-epiglottic space, thyroid cartilage, and extends to the inferior border of the cricoid cartilage. For T2 tumours, CTV2 is delineated to include bilateral cervical lymph node regions II-III. PTV1 and PTV2 are defined as the regions expanded by 3 mm outward from CTV1 and CTV2, respectively. The prescribed dose for PTV1 is 60 Gy in 30 fractions (60 Gy/30F), and the prescribed dose for PTV2 is 54 Gy in 30 fractions (54 Gy/30F). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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3-year local-regional failure-free survival (LRFS)
Prazo: From the date of surgery to the date of local recurrence, , assessed up to 3 year.
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3-year local-regional failure-free survival (LRFS): defined as the time from the date of surgery to recurrence of the primary lesion and perilesional tissues.
The index date for recurrence is the date when a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of surgery to the date of death.
For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
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From the date of surgery to the date of local recurrence, , assessed up to 3 year.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adverse events
Prazo: From enrollment to the end of treatment at 5 years.
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The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
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From enrollment to the end of treatment at 5 years.
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5-year local-regional failure-free survival (LRFS)
Prazo: From the date of surgery to the date of local recurrence, assessed up to 5 year.
|
5-year local-regional failure-free survival (LRFS): defined as the time from the date of surgery to recurrence of the primary lesion and perilesional tissues.
The index date for recurrence is the date when a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of surgery to the date of death.
For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
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From the date of surgery to the date of local recurrence, assessed up to 5 year.
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5-year overall survival (OS)
Prazo: From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
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Overall Survival(OS) is defined as the period from the date of surgery to the date of death due to any cause.
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From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
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5-year disease-free survival (DFS)
Prazo: Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.
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5-year disease-free survival (DFS): defined as the time from the date of surgery during which the patient remains alive without evidence of tumour growth.
Recurrence is defined as the emergence of new lesions, including recurrence of the primary lesion and perilesional tissues, cervical lymph-node metastasis, and distant metastasis.
The index date for recurrence is the date on which a measurable new lesion is first identified.
For patients who die of any other cause prior to documented disease recurrence, DFS is calculated from the date of surgery to the date of death.
For patients with no documented disease recurrence or death at the time of analysis (i.e., disease-free survivors), the time of the last efficacy assessment will serve as the endpoint.
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Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
16 de setembro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2031
Conclusão do estudo (Estimado)
31 de dezembro de 2031
Datas de inscrição no estudo
Enviado pela primeira vez
18 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de agosto de 2026
Primeira postagem (Real)
24 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-0861
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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