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临床试验 NCT02797366 (PRO-CNS) 针对Central Nervous System Tumour，Arteriovenous Malformation目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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乌普萨拉大学Proton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS) II期 500 开放性试验
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT02797366 (PRO-CNS)旨在研究治疗，主要针对Central Nervous System Tumour，Arteriovenous Malformation。这是一项II期 干预性研究试验，目前试验状态为招募中。试验始于2015年8月1日，计划招募500名患者。该研究由乌普萨拉大学主导，预计于2030年7月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2016年6月13日。
简要概括
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.
详细描述
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...
官方标题
Proton Radiotherapy for Primary Central Nervous System Tumours in Adults - a Prospective Swedish Multicentre Study
疾病
Central Nervous System TumourArteriovenous Malformation其他研究标识符
- PRO-CNS
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
其他Proton radiotherapy Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study. | 质子放疗 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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.
乌普萨拉大学- �...
研究中心联系人
联系人: Petra Witt Nystrom, MD, PhD, [email protected]
6 位于 1 个国家/地区的研究中心
Sahlgrenska University Hospital, Gothenburg, Sweden
Katja Werlenius, MD, 联系人
招募中
Linkoeping University Hospital, Linköping, Sweden
Anna Flejmer, MD, 联系人
招募中
Orebro University Hospital, Örebro, Sweden
Eva Tegnelius, MD, 联系人
招募中
Karolinska University Hospital, Stockholm, Sweden
Teresa Herlestam-Carlero, MD, PhD, 联系人
招募中
Umea University Hospital, Umeå, Sweden
Per Bergstrom, MD, 联系人
招募中
Uppsala University Hospital, Uppsala, Sweden
Petra Witt Nyström, Md, PhD, 联系人
招募中