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El ensayo clínico NCT02797366 (PRO-CNS) para Central Nervous System Tumour, Arteriovenous Malformation está reclutando. 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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Proton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS) Fase II 500 Etiqueta abierta

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT02797366 (PRO-CNS) está diseñado para estudiar el tratamiento de Central Nervous System Tumour, Arteriovenous Malformation. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El estudio se inició el 1 de agosto de 2015, con el objetivo de reclutar a 500 participantes. Dirigido por la Universidad de Upsala, se espera que finalice el 1 de julio de 2030. Los datos se actualizaron por última vez en ClinicalTrials.gov el 13 de junio de 2016.
Resumen
Open label, multi-centre prospective study. Adult patients with primary central nervous system tumours fulfilling the inclusion criteria according to the study protocol. The study consists of 2 sequential cohorts evaluated consecutively for the feasibility, safety and toxicity, as well as long-term survival data, when using spot scanning proton beam therapy.
Descripción detallada

Open label, multi-centre prospective phase II study. Adult patients with primary central nervous system tumours full-filling the inclusion criteria according to the study protocol. The study consists of 2 sequential cohorts evaluated for the feasibility, safety and toxicity, as well as long-term survival data, when using proton beam therapy.

  • Part I: To assess the feasibility of using pencil beam scanning and evalu...
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Título oficial

Proton Radiotherapy for Primary Central Nervous System Tumours in Adults - a Prospective Swedish Multicentre Study

Condiciones médicas
Central Nervous System TumourArteriovenous Malformation
Otros ID del estudio
  • PRO-CNS
Número del NCT
NCT02797366
Inicio del estudio (real)
2015-08
Última actualización
2016-06-13
Fecha de finalización (estimada)
2030-07
Inscripción (prevista)
500
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
OtrosProton radiotherapy
Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study.
radioterapia con protones
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Acute adverse events
3 months
Long-term adverse events
This study specifically includes longitudinal follow-up to assess the incidence of neurotoxicity including cognitive dysfunction, as well as the incidence of secondary malignant neoplasms at 10 and 15 years following radiotherapy.
10-15 years
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Local and regional tumour control
Including overall survival
15 years
Pattern of failure
Pattern of failure on MRI will be compared with patients getting conventional radiotherapy.
15 years
Quality of life
Quality of Life (QoL) data will be evaluated using validated questionnaires from the European Organization for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 is a multidimensional, cancer-specific QoL questionnaire developed for repeated assessments in clinical trials, and validated in various cancer populations. The Brain Cancer Module (EORTC-QLQ-BN20) includes 20 questions focusing on neurological symptoms and EuroQoL (EQ-5D) may additional also be used in the study.
5 years
Normal tissue sparing and normal tissue complication
Normal tissue complication probability (NTCP) models will be used to evaluate the reduction in normal tissue complications in dose planning studies comparing proton radiotherapy vs. 3D-Conformal Radiotherapy (CRT), Intensity Modulated Radiotherapy (IMRT)/Volumetric Modulated Arc Therapy (VMAT)/Helical Tomotherapy (HTT).
15 years
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • The patient must be at least 18 years old
  • World Health Organization (WHO)/ Eastern Cooperative OncologyGroup (ECOG) performance status 0-2, Karnofsky score ≥60.
  • The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial.
  • Adequate follow-up study must be possible; this will exclude a patient who is uncooperative.
  • Must have a life expectancy of at least 3 years based on age and co-morbidities as well as diagnosis. For patients considered for re-irradiation the life expectancy must be estimated to minimum 6 months.
  • Must have a pathology proven CNS tumour or if not possible, the radiology findings must be evaluated at a multi-disciplinary conference at a university hospital.
  • Women of reproductive potential must agree to use an effective method of contraception during therapy such as an intrauterine device or condom. Pregnancy IS not an ineligibility criteria if radiotherapy is indicated and can-not be postponed.
  • Prior CNS radiotherapy is not an ineligibility criteria but re-irradiated patients will be included in a subgroup evaluated separately.

Patients discussed at multidisciplinary conferences at one of the seven university hospitals in Sweden and found candidates for radiotherapy and one of following diagnoses:

  • Anaplastic glioma grade III with Loss of Heterozygosity (LOH) 1p/19q and isocitrate dehydrogenase-1 (IDH-1) mutation
  • Arteriovenous malformations (AVMs)
  • Chordomas and chondrosarcomas
  • Craniopharyngiomas
  • Ependymomas
  • Intracranial germ cell tumours
  • Low grade gliomas - grade I-II
  • Medulloblastoma, Primitive neuroectodermal tumour (PNET)
  • Meningiomas
  • Neurocytoma
  • Other grade I-II primary CNS tumour according to WHO classification
  • Pituitary adenomas
  • Schwannomas
  • Spinal tumours
  • Whenever craniospinal irradiation (CSI) is indicated
  • Whenever re-irradiation of CNS is considered

  • Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years.
  • Not able to understand information or manage tests according to study protocol. If necessary, only authorized interpreters may be used to assist in the translation.
  • Psychiatric or addictive disorders or other medical conditions that, in the opinions of the investigator, would preclude the patient from meeting the study requirements.
Uppsala University logoUniversidad de Upsala208 estudios activos para explorar
Contactos centrales del estudio
Contacto: Petra Witt Nystrom, MD, PhD, [email protected]
6 Centros del estudio en 1 países
Sahlgrenska University Hospital, Gothenburg, Sweden
Katja Werlenius, MD, Contacto
Reclutando
Linkoeping University Hospital, Linköping, Sweden
Anna Flejmer, MD, Contacto
Reclutando
Orebro University Hospital, Örebro, Sweden
Eva Tegnelius, MD, Contacto
Reclutando
Karolinska University Hospital, Stockholm, Sweden
Teresa Herlestam-Carlero, MD, PhD, Contacto
Reclutando
Umea University Hospital, Umeå, Sweden
Per Bergstrom, MD, Contacto
Reclutando
Uppsala University Hospital, Uppsala, Sweden
Petra Witt Nyström, Md, PhD, Contacto
Reclutando