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L'essai clinique NCT02797366 (PRO-CNS) pour Central Nervous System Tumour, Arteriovenous Malformation est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université d’UppsalaProton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS) Phase II 500 Ouvert
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT02797366 (PRO-CNS) est conçu pour étudier le traitement de Central Nervous System Tumour, Arteriovenous Malformation. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : en recrutement. L'étude a débuté le 1 août 2015 et vise à recruter 500 participants. Dirigée par l'Université d’Uppsala, l'étude devrait être terminée d'ici le 1 juillet 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 13 juin 2016.
Résumé succinct
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.
Description détaillée
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...
Titre officiel
Proton Radiotherapy for Primary Central Nervous System Tumours in Adults - a Prospective Swedish Multicentre Study
Pathologies
Central Nervous System TumourArteriovenous MalformationAutres identifiants de l'étude
- PRO-CNS
Numéro NCT
Date de début (réel)
2015-08
Dernière mise à jour publiée
2016-06-13
Date de fin (estimée)
2030-07
Inscription (estimée)
500
Type d'étude
Interventionnel
PHASE
Phase II
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
AutreProton radiotherapy Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study. | radiothérapie par protons |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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.
Université d’Uppsala- �...
Contact central de l'étude
Contact: Petra Witt Nystrom, MD, PhD, [email protected]
6 Centres de l'étude dans 1 pays
Sahlgrenska University Hospital, Gothenburg, Sweden
Katja Werlenius, MD, Contact
En recrutement
Linkoeping University Hospital, Linköping, Sweden
Anna Flejmer, MD, Contact
En recrutement
Orebro University Hospital, Örebro, Sweden
Eva Tegnelius, MD, Contact
En recrutement
Karolinska University Hospital, Stockholm, Sweden
Teresa Herlestam-Carlero, MD, PhD, Contact
En recrutement
Umea University Hospital, Umeå, Sweden
Per Bergstrom, MD, Contact
En recrutement
Uppsala University Hospital, Uppsala, Sweden
Petra Witt Nyström, Md, PhD, Contact
En recrutement