Hypofractionated Radiotherapy in Older Adults With Head and Neck Squamous Cell Carcinoma
Clinical Outcomes and Toxicity of Hypofractionated Radiotherapy in Older Adults With Head and Neck Squamous Cell Carcinoma
Standard radiotherapy for head and neck squamous cell carcinoma typically requires daily treatments over 6 to 7 weeks. For older adults, these prolonged treatment schedules can cause substantial physical fatigue, travel burden, and treatment interruptions. Hypofractionated radiotherapy delivers higher doses of radiation per session over a shorter total treatment time (approximately 3 weeks), potentially limiting tumor cell regrowth, easing logistical demands on patients, and improving completion rates.
The purpose of this randomized controlled trial is to evaluate the clinical effectiveness, safety, and toxicity of hypofractionated radiotherapy compared with standard normofractionated radiotherapy in older adults with non-metastatic head and neck squamous cell carcinoma.
Eligible participants aged 65 years and older will be randomly assigned in a 1:1 ratio to receive either:
- Hypofractionated Radiotherapy (Intervention): External beam radiotherapy delivered via image-guided intensity-modulated techniques (IMRT/VMAT) once daily over approximately 3 weeks (45 Gy in 15 fractions for definitive therapy, or 40.5 Gy in 15 fractions for postoperative/adjuvant therapy).
- Standard Normofractionated Radiotherapy (Comparator): External beam radiotherapy delivered once daily using conventional fractionation schedules over approximately 6 to 7 weeks according to institutional clinical standards.
Participants will be monitored weekly during radiation treatment and followed for up to 1 year post-treatment. The primary outcome is locoregional control, with secondary outcomes assessing overall survival, disease-free survival, acute and late toxicities graded by CTCAE version 6.0, and health-related quality of life.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma of the head and neck.
- Age ≥ 65 years.
- Non-metastatic disease (M0).
- Early-stage or locally advanced disease considered suitable for definitive or postoperative radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Adequate baseline organ function to safely undergo radiotherapy (including adequate hematological, renal, and hepatic function according to institutional criteria).
- No prior radiation therapy delivered to the head and neck region.
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Presence of distant metastases (M1) at enrollment.
- ECOG performance status > 2.
- Severe uncontrolled comorbidities that make radiotherapy unsafe.
- Inability to comply with treatment planning, immobilization, or protocol follow-up requirements.
- Refusal or inability to provide written informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Hypofractionated Radiotherapy
Eligible older adults receive hypofractionated external beam radiotherapy using image-guided intensity-modulated radiotherapy (IMRT/VMAT). For definitive radiotherapy, a total dose of 45 Gy in 15 fractions (3 Gy per fraction) will be administered once daily, 5 fractions per week, over approximately 3 weeks. For postoperative/adjuvant radiotherapy, a total dose of 40.5 Gy in 15 fractions (2.7 Gy per fraction) will be administered once daily, 5 fractions per week, over approximately 3 weeks. |
External beam radiotherapy administered using image-guided intensity-modulated radiotherapy (IMRT/VMAT) techniques. In the definitive setting, patients receive a total dose of 45 Gy in 15 fractions (3 Gy per fraction), delivered once daily, 5 fractions per week over approximately 3 weeks. In the postoperative/adjuvant setting, patients receive a total dose of 40.5 Gy in 15 fractions (2.7 Gy per fraction), delivered once daily, 5 fractions per week over approximately 3 weeks. |
|
Comparador activo: Standard Normofractionated Radiotherapy
Eligible older adults receive standard normofractionated external beam radiotherapy according to institutional clinical practice guidelines (conventional fractionation, typically 1.8-2.0 Gy per fraction once daily, 5 fractions per week over 6-7 weeks) for definitive or postoperative head and neck squamous cell carcinoma. |
Standard external beam radiotherapy administered according to institutional protocols using conventional fractionation schedules (1.8-2.0 Gy per fraction, once daily, 5 fractions per week over 6-7 weeks) for definitive or postoperative management of head and neck squamous cell carcinoma. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Locoregional Control (LRC) Rate
Periodo de tiempo: 1 year after completion of radiotherapy
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Locoregional control is defined as the proportion of participants without evidence of persistent, recurrent, or progressive tumor at the primary disease site or regional cervical lymph nodes, assessed via clinical examination and diagnostic imaging. |
1 year after completion of radiotherapy
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Carcinoma De Células Escamosas
- Carcinoma de células escamosas de cabeza y cuello
- Neoplasias de Cabeza y Cuello
- Terapéutica
- Radioterapia
- Fraccionamiento de dosis, radiación
- Dosis de radioterapia
- Hipofraccionamiento de dosis de radiación
Otros números de identificación del estudio
- HypoRT in Older HNSCC Patients
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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