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क्लिनिकल ट्रायल NCT02797366 (PRO-CNS) के लिए Central Nervous System Tumour, Arteriovenous Malformation वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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Proton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS) चरण II 500 ओपन-लेबल

भर्ती जारी
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT02797366 (PRO-CNS) का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन Central Nervous System Tumour, Arteriovenous Malformation से जुड़ा हुआ है और यह एक चरण II हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 1 अगस्त 2015 को हुई थी, और इसमें कुल 500 प्रतिभागियों के नामांकन की योजना है। उप्साला विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 जुलाई 2030 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 13 जून 2016 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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.
विस्तृत विवरण

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...
और दिखाएँ
आधिकारिक शीर्षक

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

स्वास्थ्य स्थितियां
Central Nervous System TumourArteriovenous Malformation
अन्य अध्ययन आईडी
  • PRO-CNS
NCT नंबर
NCT02797366
अध्ययन प्रारंभ तिथि (वास्तविक)
2015-08
अंतिम अद्यतन प्रकाशित
2016-06-13
अध्ययन की समाप्ति तिथि (अनुमानित)
2030-07
नामांकन (अनुमानित)
500
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण II
स्थिति
भर्ती जारी
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
अन्यProton radiotherapy
Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study.
प्रोटॉन रेडियोथेरेपी
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
  • 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 logoउप्साला विश्वविद्यालय
अध्ययन केंद्रीय संपर्क
संपर्क: Petra Witt Nystrom, MD, PhD, [email protected]
6 1 देशों में अध्ययन स्थान
Sahlgrenska University Hospital, Gothenburg, Sweden
Katja Werlenius, MD, संपर्क
भर्ती जारी
Linkoeping University Hospital, Linköping, Sweden
Anna Flejmer, MD, संपर्क
भर्ती जारी
Orebro University Hospital, Örebro, Sweden
Eva Tegnelius, MD, संपर्क
भर्ती जारी
Karolinska University Hospital, Stockholm, Sweden
Teresa Herlestam-Carlero, MD, PhD, संपर्क
भर्ती जारी
Umea University Hospital, Umeå, Sweden
Per Bergstrom, MD, संपर्क
भर्ती जारी
Uppsala University Hospital, Uppsala, Sweden
Petra Witt Nyström, Md, PhD, संपर्क
भर्ती जारी