A Pilot Study of Ultra-High Dose Rate (ConformalFLASH®), for Reirradiation of Carcinoma of the Head and Neck (C-FLASH-01)
11 de junio de 2026 actualizado por: IBA Proton Therapy, Inc.
This pilot study is designed to evaluate the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) in participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection.
ConformalFLASH treatment planning and delivery workflows are comparable to those of conventional Stereotactic Body Radiation Therapy (SBRT), a standard approach for re-irradiation in this population.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
C-FLASH-01 is a pilot study evaluating the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) to participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection.
Stereotactic Body Radiation Therapy (SBRT) re-irradiation is a standard approach that enables highly conformal dose delivery over a limited number of fractions.
ConformalFLASH is an investigational approach that applies SBRT principles using proton therapy delivered at ultra-high dose rates (≥ 40 Gray Relative Biological Effectiveness (GyRBE)/second), with the potential to reduce normal tissue toxicity while maintaining tumor control.
Participants will undergo treatment planning and delivery consistent with standard SBRT workflows.
Treatment consists of five fractions (8 GyRBE per fraction) delivered over approximately 1.5 to 2 weeks.
The primary objective is to assess the feasibility of delivering conformal proton SBRT at dose rates ≥ 40 GyRBE/second, along with evaluation of acute toxicity.
Secondary objectives include assessment of treatment delivery accuracy, late toxicity, clinical outcomes, and patient-reported quality of life.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
10
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: Sophie Le Bail
- Número de teléfono: +32 470 226 032
- Correo electrónico: sophie.lebail@iba-group.com
Copia de seguridad de contactos de estudio
- Nombre: Sofie Gillis
- Número de teléfono: +32 499 985 686
- Correo electrónico: sofie.Gillis@iba-group.com
Ubicaciones de estudio
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- The University of Pennsylvania, Department of Radiation Oncology
-
Contacto:
- Alexander Lin, MD
-
-
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:
- Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
- Patients ≥ 18 years old
- Patients ineligible for or decline upfront surgical resection
- Histologically confirmed diagnosis of carcinoma of the head and neck
- Prior receipt of at least 45 GyRBE radiotherapy to the head and neck
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or evidence of similar in the electronic medical record
- Life expectancy of more than 12 weeks
- Ability to understand and the willingness to provide written informed consent and to follow the study procedures
Exclusion Criteria:
- Receipt of prior head and neck radiotherapy within the prior 6 months
- Surgical resection of the current disease in the head and neck
- More than 3 areas of disease requiring reirradiation
- Disease focus exceeding 6.5 cm in greatest dimension
- Presence of distant metastatic disease
- Involvement of any of the following structures: skin, carotid artery, or mandible
- Receipt of concurrent chemotherapy during radiotherapy
- Uncontrolled intercurrent illness including medical and psychiatric, and social situations that would limit compliance with study requirements
- Enrolled in any other investigational studies that involve administrations of another cancer therapeutic (such as surgery, chemotherapy, immunotherapy) during RT
- Pregnant and/or breastfeeding
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: Treatment Arm
ConformalFLASH irradiation
|
Subjects will be treated with SBRT (8 GyRBE x 5 fractions over 1.5-2 weeks), using pencil-beam scanning proton therapy, delivered at an average dose rate of ≥ 40 GyRBE/second, without chemotherapy.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ConformalFLASH treatment delivery feasibility
Periodo de tiempo: Through treatment completion (within 1 month after last fraction)
|
Delivery of ≥ 95% of the prescribed dose to ≥ 95% of the clinical target volume (CTV) at an average dose rate of ≥ 40 GyRBE/second
|
Through treatment completion (within 1 month after last fraction)
|
|
Acute toxicities
Periodo de tiempo: Up to 3 months after treatment start
|
Incidence of acute toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 6.0
|
Up to 3 months after treatment start
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ConformalFLASH treatment delivery accuracy
Periodo de tiempo: Through treatment completion (within 1 month after last fraction)
|
Dose delivered to the clinical target volume (CTV) and organs at risk (OARs) as well as the average dose rate to the CTV
|
Through treatment completion (within 1 month after last fraction)
|
|
Late toxicities
Periodo de tiempo: Beyond 3 months after start of treatment and up to 5 years
|
Incidence of late toxicity as assessed by CTCAE version 6.0
|
Beyond 3 months after start of treatment and up to 5 years
|
|
Local Control
Periodo de tiempo: 3 months and 1 year
|
Absence of tumor recurrence or progression at the primary radiated disease site following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
|
3 months and 1 year
|
|
Regional control
Periodo de tiempo: 3 months and 1 year
|
Absence of tumor recurrence or progression in regional lymph nodes following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
|
3 months and 1 year
|
|
Metastasis-free survival
Periodo de tiempo: 3 months and 1 year
|
Time from first treatment to the first occurrence of distant metastatic disease or death from any cause.
|
3 months and 1 year
|
|
Overall survival
Periodo de tiempo: 3 months and 1 year
|
Time from first treatment to death from any cause
|
3 months and 1 year
|
|
Patient-reported quality of life
Periodo de tiempo: Up to 5 years
|
Effect of the treatment on patient-reported quality of life, using the University of Washington Quality of Life Questionnaire (UW-QOL).The UW-QOL consists of domains based upon discrete ordinal responses regarding their past 7 days. Scoring is scaled so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. The UW-QOL comprises 12 single-question domains, each between 3 and 6 response options. These options are scaled evenly from 0 (worst) to 100 (best), according to the hierarchy of response. Each domain is scored individually, and an overall composite score can be derived. In addition, patients are asked to choose up to 3 of these domains that they consider most important to them. The UW-QOL also includes 3 global questions, one about how patient feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL. |
Up to 5 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alexander Lin, MD, University of Pennsylvania
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Vargo JA, Ferris RL, Ohr J, Clump DA, Davis KS, Duvvuri U, Kim S, Johnson JT, Bauman JE, Gibson MK, Branstetter BF, Heron DE. A prospective phase 2 trial of reirradiation with stereotactic body radiation therapy plus cetuximab in patients with previously irradiated recurrent squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):480-8. doi: 10.1016/j.ijrobp.2014.11.023. Epub 2015 Jan 30.
- Heron DE, Ferris RL, Karamouzis M, Andrade RS, Deeb EL, Burton S, Gooding WE, Branstetter BF, Mountz JM, Johnson JT, Argiris A, Grandis JR, Lai SY. Stereotactic body radiotherapy for recurrent squamous cell carcinoma of the head and neck: results of a phase I dose-escalation trial. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1493-500. doi: 10.1016/j.ijrobp.2008.12.075. Epub 2009 May 21.
- Lartigau EF, Tresch E, Thariat J, Graff P, Coche-Dequeant B, Benezery K, Schiappacasse L, Degardin M, Bondiau PY, Peiffert D, Lefebvre JL, Lacornerie T, Kramar A. Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer. Radiother Oncol. 2013 Nov;109(2):281-5. doi: 10.1016/j.radonc.2013.08.012. Epub 2013 Nov 18.
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)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2032
Fechas de registro del estudio
Enviado por primera vez
2 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de junio de 2026
Publicado por primera vez (Actual)
12 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IBA-04-UP
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.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .