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임상시험 NCT02797366 (PRO-CNS)은(는) Central Nervous System Tumour, Arteriovenous Malformation에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Proton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS) 2상 500 오픈 라벨

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임상시험 NCT02797366 (PRO-CNS)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Central Nervous System Tumour, Arteriovenous Malformation에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2015년 8월 1일에 시작되어 500명의 참여자를 모집하고 있습니다. 웁살라 대학교이(가) 진행하며, 2030년 7월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2016년 6월 13일에 갱신되었습니다.
간단한 개요
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.
상세한 설명

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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공식 제목

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

질환명
Central Nervous System TumourArteriovenous Malformation
기타 연구 식별자
  • PRO-CNS
NCT 번호
NCT02797366
실제 연구 시작일
2015-08
최신 업데이트 게시
2016-06-13
예상 연구 완료일
2030-07
계획된 등록 인원
500
연구종류
중재연구
단계/상
2상
상태
모집중
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
기타Proton radiotherapy
Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study.
양성자 방사선 치료
주요결과변수
결과변수측정값 설명시간 범위
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
이차결과변수
결과변수측정값 설명시간 범위
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
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
  • 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 logo웁살라 대학교
연구 대표 연락처
연락처: Petra Witt Nystrom, MD, PhD, [email protected]
6 1개국에 임상시험 장소
Sahlgrenska University Hospital, Gothenburg, Sweden
Katja Werlenius, MD, 연락처
모집중
Linkoeping University Hospital, Linköping, Sweden
Anna Flejmer, MD, 연락처
모집중
Orebro University Hospital, Örebro, Sweden
Eva Tegnelius, MD, 연락처
모집중
Karolinska University Hospital, Stockholm, Sweden
Teresa Herlestam-Carlero, MD, PhD, 연락처
모집중
Umea University Hospital, Umeå, Sweden
Per Bergstrom, MD, 연락처
모집중
Uppsala University Hospital, Uppsala, Sweden
Petra Witt Nyström, Md, PhD, 연락처
모집중