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El ensayo clínico NCT07412327 para Early-Stage Lung Cancer, Cáncer de pulmón está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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A Single-Center, Prospective Phase II Clinical Study of Proton Beam Intensity-Modulated Stereotactic Radiotherapy for Early-Stage Non-Small Cell Lung Cancer 65 Corto plazo

Aún no recluta
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El ensayo clínico NCT07412327 es un estudio intervencionista para Early-Stage Lung Cancer, Cáncer de pulmón. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 20 de febrero de 2026 hasta completar 65 participantes. Dirigido por Guangzhou Concord Cancer Center, se espera que finalice el 1 de julio de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 17 de febrero de 2026.
Resumen
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (AJCC eighth edition staging) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical proton hypofractionated radiotherapy. The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central...Mostrar más
Título oficial

A Single-Center, Prospective Phase II Clinical Study of Proton Beam Intensity-Modulated Stereotactic Radiotherapy for Early-Stage Non-Small Cell Lung Cancer

Condiciones médicas
Early-Stage Lung CancerCáncer de pulmón
Otros ID del estudio
  • 2025-IIT-002
Número del NCT
NCT07412327
Inicio del estudio (real)
2026-02-20
Última actualización
2026-02-17
Fecha de finalización (estimada)
2029-07-01
Inscripción (prevista)
65
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
Proton therapy
hypofractionated radiotherapy
radiotherapy
Early-Stage Lung Cancer
lung cancer
SBPT
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalStereotactic Body Proton Therapy
The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.
Stereotactic Body Proton Therapy
They were divided into peripheral type and central type according to the tumor location and received radical proton hypofractionated radiotherapy. The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Progression-free Survival
Progression Free Survival is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method
Up to 3 years
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Overall Survival
Overall Survival is defined as time from initiation of SBPT to patient death from any cause. Estimated by the Kaplan-Meier method.
UP to 3 years
Local Control Rate
Local control rate is defined as the proportion of participants with the absence of local failure among patients evaluable for efficacy in three years.
Up to 3 years
Quality of life scores
QLQ-C30(V3.0) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit
Up to 3 years
Quality of life scores
QLQ-LC29 scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit
Up to 3 years
Rate of grade 3-5 adverse events
The proportion of subjects with toxic reactions of levels 3, 4 and 5 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0)
Up to 3 years
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  1. .Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the clinical diagnosis of lung cancer is confirmed after MDT discussion.
  2. The clinical staging based on PET-CT examination is: cT1~3 N0M0, stage IA-IIB (AJCC eighth edition).
  3. Age: 18 years and above.
  4. KPS score ≥60.
  5. The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
  6. Relatively good organ function:
  7. Normal bone marrow function: WBC≥3×109/L, Platelet ≥80×109/L, HGB≥90g/L
  8. Normal liver and kidney function:
  9. Total bilirubin, AST, and ALT≤2.0×upper limit of normal values;
  10. Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
  11. The patient has signed an informed consent form and is willing and able to comply with planned study visits, treatment plans, laboratory tests, and other study procedures.

  1. Patients with other malignant tumors.
  2. Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
  3. Those whose laboratory test values do not meet relevant standards before enrollment.
  4. Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
  5. Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
  6. Patients considered inappropriate for inclusion by other investigators.
Guangzhou Concord Cancer Center logoGuangzhou Concord Cancer Center
No hay datos de contacto.
1 Centros del estudio en 1 países

Guangdong

Guangzhou Concord Cancer Center, Guangzhou, Guangdong, China