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O estudo clínico NCT02797366 (PRO-CNS) para Central Nervous System Tumour, Arteriovenous Malformation está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Proton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS) Fase II 500 Estudo aberto

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT02797366 (PRO-CNS) procura avaliar tratamento para Central Nervous System Tumour, Arteriovenous Malformation. Este é um estudo intervencionista de Fase II. Seu status atual é: em recrutamento. O estudo começou em 1 de agosto de 2015 e pretende incluir 500 participantes. Coordenado por a Universidade de Uppsala e deve ser concluído em 1 de julho de 2030. Essas informações foram atualizadas no ClinicalTrials.gov em 13 de junho de 2016.
Resumo
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.
Descrição detalhada

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

Condições médicas
Central Nervous System TumourArteriovenous Malformation
Outros IDs do estudo
  • PRO-CNS
Número NCT
NCT02797366
Data de início (real)
2015-08
Última atualização postada
2016-06-13
Data de conclusão (estimada)
2030-07
Inscrição (estimada)
500
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Em recrutamento
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
OutroProton radiotherapy
Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study.
radioterapia com prótons
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
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 logoUniversidade de Uppsala208 estudos clínicos ativos para explorar
Contato central do estudo
Contato: Petra Witt Nystrom, MD, PhD, [email protected]
6 Locais do estudo em 1 países
Sahlgrenska University Hospital, Gothenburg, Sweden
Katja Werlenius, MD, Contato
Em recrutamento
Linkoeping University Hospital, Linköping, Sweden
Anna Flejmer, MD, Contato
Em recrutamento
Orebro University Hospital, Örebro, Sweden
Eva Tegnelius, MD, Contato
Em recrutamento
Karolinska University Hospital, Stockholm, Sweden
Teresa Herlestam-Carlero, MD, PhD, Contato
Em recrutamento
Umea University Hospital, Umeå, Sweden
Per Bergstrom, MD, Contato
Em recrutamento
Uppsala University Hospital, Uppsala, Sweden
Petra Witt Nyström, Md, PhD, Contato
Em recrutamento