رادار التجارب AI
حالة التجربة السريرية NCT02797366 (PRO-CNS) لـ Central Nervous System Tumour، Arteriovenous Malformation هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة

Proton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS) المرحلة الثانية ٥٠٠ تجربة مفتوحة

يقبل مشاركين
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT02797366 (PRO-CNS) مصممة لدراسة علاج لـCentral Nervous System Tumour، Arteriovenous Malformation. إنها تجربة تدخُّلية من المرحلة الثانية وهي يقبل مشاركين. بدأت في ١٦ شوال ١٤٣٦ هـ مع خطة لتجنيد ٥٠٠ مشاركًا. تقودها جامعة أبسالة، ومن المتوقع اكتمالها بحلول ٢٩ صفر ١٤٥٢ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٨ رمضان ١٤٣٧ هـ.
الملخص
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.
وصف مفصل

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...
عرض المزيد
العنوان الرسمي

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

الحالات الطبية
Central Nervous System TumourArteriovenous Malformation
معرّفات دراسة أخرى
  • PRO-CNS
NCT معرّف
تاريخ البدء (فعلي)
2015-08
آخر تحديث مُنشور
2016-06-13
تاريخ الاكتمال (المقدر)
2030-07
عدد المشاركين المخطط لهم
٥٠٠
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الثانية
الحالة
يقبل مشاركين
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
غ/م
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
أخرىProton radiotherapy
Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study.
العلاج الإشعاعي بالبروتون
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
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
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
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
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • 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 logoجامعة أبسالة
جهة اتصال مركزية للدراسة
جهة اتصال: Petra Witt Nystrom, MD, PhD, [email protected]
6 مواقع الدراسة في 1 بلدان
Sahlgrenska University Hospital, Gothenburg, Sweden
Katja Werlenius, MD, جهة اتصال
يقبل مشاركين
Linkoeping University Hospital, Linköping, Sweden
Anna Flejmer, MD, جهة اتصال
يقبل مشاركين
Orebro University Hospital, Örebro, Sweden
Eva Tegnelius, MD, جهة اتصال
يقبل مشاركين
Karolinska University Hospital, Stockholm, Sweden
Teresa Herlestam-Carlero, MD, PhD, جهة اتصال
يقبل مشاركين
Umea University Hospital, Umeå, Sweden
Per Bergstrom, MD, جهة اتصال
يقبل مشاركين
Uppsala University Hospital, Uppsala, Sweden
Petra Witt Nyström, Md, PhD, جهة اتصال
يقبل مشاركين