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治験 NCT02797366 (PRO-CNS)（対象：Central Nervous System Tumour、Arteriovenous Malformation）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ウプサラ大学Proton Radiotherapy for Primary Central Nervous System Tumours in Adults (PRO-CNS) 第II相・フェーズ2 500 非盲検
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT02797366 (PRO-CNS) は Central Nervous System Tumour、Arteriovenous Malformation に関する 治療 の研究で、第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2015年8月1日 から開始しています。500 名の参加者 の募集が計画されています。この試験は ウプサラ大学 によって主導され、2030年7月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2016年6月13日 です。
概要
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.
詳細説明
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...
公式タイトル
Proton Radiotherapy for Primary Central Nervous System Tumours in Adults - a Prospective Swedish Multicentre Study
疾患名
Central Nervous System TumourArteriovenous Malformationその他の研究識別子
- PRO-CNS
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
その他Proton radiotherapy Proton radiation therapy daily (Monday through Friday) for 4-8 weeks. This is a single arm study. | 陽子線治療 |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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.
ウプサラ大学208 件のアクティブな治験を探索- �...
試験中央連絡先
連絡先: Petra Witt Nystrom, MD, PhD, [email protected]
6 1カ国の場所
Sahlgrenska University Hospital, Gothenburg, Sweden
Katja Werlenius, MD, 連絡先
募集中
Linkoeping University Hospital, Linköping, Sweden
Anna Flejmer, MD, 連絡先
募集中
Orebro University Hospital, Örebro, Sweden
Eva Tegnelius, MD, 連絡先
募集中
Karolinska University Hospital, Stockholm, Sweden
Teresa Herlestam-Carlero, MD, PhD, 連絡先
募集中
Umea University Hospital, Umeå, Sweden
Per Bergstrom, MD, 連絡先
募集中
Uppsala University Hospital, Uppsala, Sweden
Petra Witt Nyström, Md, PhD, 連絡先
募集中