Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation
20 de agosto de 2026 actualizado por: Second Affiliated Hospital, Zhejiang University, School of Medicine
Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation: 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.
Surgery is the predominant treatment modality for patients with early-stage glottic carcinoma in China.
Patients with poorly-differentiated early-stage glottic carcinoma exhibit inferior local control after surgery compared with those with moderately-to-well-differentiated tumours.
Data from our previous retrospective study suggest that definitive radiotherapy/postoperative radiotherapy yields superior local control compared with surgery alone for poorly-differentiated early-stage glottic carcinoma.
We hypothesize that definitive radiotherapy and postoperative radiotherapy can improve local control rates in patients with poorly-differentiated early-stage glottic squamous cell carcinoma.
This study aims to conduct a multicenter, prospective, single-arm phase II clinical trial using intensity-modulated radiotherapy (IMRT) for patients with poorly-differentiated early-stage glottic laryngeal carcinoma, to preliminarily evaluate the impact of IMRT on local control rates and long-term survival outcomes in this patient population.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
38
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Dongjun Dai, Doctor
- Número de teléfono: 86-0571-86992821
- Correo electrónico: daidongjunmed@zju.edu.cn
Ubicaciones de estudio
-
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310009
- Reclutamiento
- Second Affiliated Hospital of Zhejiang University School of Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥18 years, any gender
- Histologically proven glottic squamous cell carcinoma
- T1 T2N0M0 glottic laryngeal carcinoma with poor differentiation (moderate poor differentiation counted as poor differentiation)
- Subjects undergoing curative intent surgery must be enrolled 4 8 weeks after operation.
- No prior chemoradiotherapy or antineoplastic therapy
- ECOG PS 0 1
- Written informed consent provided
Exclusion Criteria:
- Moderately or well differentiated tumours
- Prior chemotherapy or other antineoplastic agents
- Prior head and neck irradiation
- Previous participation in another clinical trial
- Severe allergic history including contrast media allergy
- Pregnancy or lactation
- Uncontrolled acute infection
- Drug/substance abuse, chronic heavy drinking, HIV infection
- Uncontrolled concomitant malignant disease
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Radiotherapy
intensity modulated radiotherapy (IMRT)
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Post operative radiotherapy (CTV): CTV1 is routine postoperative laryngeal target covering whole larynx, piriform sinus, glosso epiglottic vallecula, paraglottic space, pre epiglottic space, thyroid cartilage down to inferior border of cricoid cartilage. Given higher lymphatic metastatic risk of poorly differentiated tumours, CTV2 delineates bilateral cervical nodal levels II III. PTV1/PTV2 are 3 mm isotropic expansions of CTV1/CTV2. Prescription: PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions. Definitive radiotherapy targets: Additional GTV denotes macroscopic tumour identified by laryngoscopy and imaging. PGTV/PTV1/PTV2 are 3 mm isotropic expansions of GTV/CTV1/CTV2. Prescription: PGTV 66 Gy/30 fractions; PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
3-year local-regional failure-free survival (LRFS)
Periodo de tiempo: From the date of enrollment to the date of local recurrence, , assessed up to 3 year.
|
3-year local-regional failure-free survival (LRFS): defined as the time from the date of enrollment 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 enrollment 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 enrollment to the date of local recurrence, , assessed up to 3 year.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
5-year local-regional failure-free survival (LRFS)
Periodo de tiempo: From the date of enrollment 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 enrollment 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 enrollment 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.
|
From the date of enrollment to the date of local recurrence, assessed up to 5 year.
|
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5-year overall survival (OS)
Periodo de tiempo: From the date of enrollment until the date of death due to any cause, assessed up to 5 year.
|
Overall Survival(OS) is defined as the period from the date of enrollment to the date of death due to any cause.
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From the date of enrollment until the date of death due to any cause, assessed up to 5 year.
|
|
5-year disease-free survival (DFS)
Periodo de tiempo: Time from the date of enrollment to any evidence of tumour growth or death, assessed up to 5 year.
|
5-year disease-free survival (DFS): defined as the time from the date of enrollment 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 enrollment 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 enrollment to any evidence of tumour growth or death, assessed up to 5 year.
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Adverse events
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
16 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2030
Finalización del estudio (Estimado)
31 de diciembre de 2031
Fechas de registro del estudio
Enviado por primera vez
18 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-1250
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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