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Time Trends in Waiting Times of NSCLC Patients.

29 de septiembre de 2015 actualizado por: Maastricht Radiation Oncology

Time Trends in Diagnostic Delay and Waiting Times of Four Patient Cohorts, Diagnosed With Non-small Cell Lung Cancer, Treated With High Dose Radiotherapy.

A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery of very high radiation doses is needed to obtain local control, but due to the large tumor and nodal volume this is often impossible without causing unrepairable damage to the normal tissue of the mediastinum, spinal cord, esophagus and lung.

Although every tumor is different with respect to the speed with which it grows and spreads, it is obvious that time plays an important role in cancer therapy. Recently it was reported that disease progression or increase of tumor volume occurred during the time interval between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment and consequently have an impact on overall survival. Moreover, the increasing number of diagnostic procedures, aimed at obtaining more accurate information about the tumor extension and biology, as well as the use of more sophisticated but labor intense radiation techniques could prolong the time interval between clinical symptoms and the start of the treatment. However, the influence of new diagnostic procedures or the applied radiotherapy techniques on waiting times is not yet known. The investigators therefore want to investigate 1) time trends in the waiting time for NSCLC patients, 2) the correlation between waiting times and the use of more advanced diagnostic or therapeutic procedures, and 3) the correlation between waiting times and overall survival.

The hypotheses of the study:

  1. The diagnostic delay for NSCLC patients has increased during the last 12 years.
  2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12 years.
  3. Prolonged waiting times are associated with worse overall survival outcome.

Descripción general del estudio

Estado

Retirado

Descripción detallada

A large group of non-small cell lung cancer patients is treated with radiotherapy. Delivery of very high radiation doses is needed to obtain local control, but due to the large tumor and nodal volume this is often impossible without causing unrepairable damage to the normal tissue of the mediastinum, spinal cord, esophagus and lung.

Although every tumor is different with respect to the speed with which it grows and spreads, it is obvious that time plays an important role in cancer therapy. Recently it was reported that disease progression or increase of tumor volume occurred during the time interval between diagnosis and treatment.(1, 2) This could lead to a less optimal radiation treatment and consequently have an impact on overall survival. Moreover, the increasing number of diagnostic procedures, aimed at obtaining more accurate information about the tumor extension and biology, as well as the use of more sophisticated but labor intense radiation techniques could prolong the time interval between clinical symptoms and the start of the treatment. However, the influence of new diagnostic procedures or the applied radiotherapy techniques on waiting times is not yet known. The investigators therefore want to investigate 1) time trends in the waiting time for NSCLC patients, 2) the correlation between waiting times and the use of more advanced diagnostic or therapeutic procedures, and 3) the correlation between waiting times and overall survival.

The hypotheses of the study:

  1. The diagnostic delay for NSCLC patients has increased during the last 12 years.
  2. The preparation time for radiotherapy of NSCLC patients has increased during the last 12 years.
  3. Prolonged waiting times are associated with worse overall survival outcome.

The IKL collected data on waiting times and treatment of NSCLC patients treated in 2001 and 2004. These data will be used for this project. In addition, the MAASTRO lung database contains information of patients treated in 2006 and 2010. Additional information about the diagnostic procedure and radiation treatment preparation will be collected by reviewing the patient charts. For this study a data request has to be submitted to the IKL and access to MAASTRO patient data (charts and EMD) is needed.

The investigators aim to collect the following variables: Date of consultation pulmonologist; Date of multidisciplinary meeting; Date of first consultancy at radiotherapy; Date of start radiotherapy; Information about diagnostic procedure (PET/CT/Pathology/EBUS/EUS); Information about RT procedure (3Dconventional/IMRT); General patient characteristics; Overall survival

Tipo de estudio

De observación

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.

Ubicaciones de estudio

    • Limburg
      • Maastricht, Limburg, Países Bajos, 6229 ET
        • Maastro clinic

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Four cohorts of NSCLC patients will be analyzed. Patients were all treated with radiotherapy with or without chemotherapy. To investigate the time trends, cohorts referred for radiotherapy treatment in 2001, 2004, 2006 and 2010 will be analyzed.

Descripción

Inclusion Criteria:

Patients with NSCLC treated in the Dutch province Limburg from 2001 onwards.

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

Cohortes e Intervenciones

Grupo / Cohorte
Radiotherapy in 2001
Radiotherapy in 2004
Radiotherapy in 2006
Radiotherapy in 2010

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Analysis of waiting times
Periodo de tiempo: From intake to start of radiotherapy
Retrospective analysis of the time passed between consultation and start of radiotherapy (an expected average time frame of two weeks).
From intake to start of radiotherapy
Correlation of waiting times and treatment outcome
Periodo de tiempo: From treatment until date of censoring (12 years)
Is there a correlation between the time passed between consultation and start of radiotherapy and treatment outcome? (Time frame: 12 years)
From treatment until date of censoring (12 years)

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

1 de diciembre de 2015

Finalización primaria (Anticipado)

1 de septiembre de 2016

Finalización del estudio (Anticipado)

1 de septiembre de 2016

Fechas de registro del estudio

Enviado por primera vez

3 de septiembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

16 de septiembre de 2013

Publicado por primera vez (Estimar)

19 de septiembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de septiembre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2015

Última verificación

1 de septiembre de 2015

Más información

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. .

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