DRKS00016667已完成1 期
PriCoTTF Trial: A phase I/II trial of TTFields prior and concomitant to radiotherapy in newly diagnosed glioblastoma - PriCoTTF
niversitätsklinikum Essen0 个研究点目标入组 33 人开始时间: 2019年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Pathological evidence of glioblastoma or gliosarcoma using latest WHO classification criteria
- •Negative IDH status on immunohistochemistry or sequencing
- •Patient received brain tumor resection or biopsy and further treatment regime foresees radiotherapy with or without concomitant chemotherapy
- •General indication for whole treatment regimen was a common deci-sion of a multidisciplinary team within brain tumor board and in accordance with the national and/or international guidelines for the treatment of glioblastoma patients
- •KPS = 60% (Study arm A), KPS = 50% (Study arm B)
- •Life expectancy at least 3 months
- •Participants of child-bearing age must use effective contraception
- •Treatment with TTFields may start 2-4 weeks post resection and 1-2 weeks prior to radiotherapy
- •Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- •Written informed consent of the subject
排除标准
- •General Exclusion Criteria:
- •Subjects not able to give consent
- •Subject without legal capacity who is unable to understand the nature, scope, significance, and consequences of this clinical trial
- •Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
- •Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk may confound the trial results or may interfere with the subject’s participation in this clinical trial
- •Known or persistent abuse of medication, drugs or alcohol
- •Exclusion criteria regarding special restrictions for females:
- •Current or planned pregnancy or nursing women
- •Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- •Indication-specific exclusion criteria:
- •Infra-tentorial tumor
- •Significant comorbidities at baseline, which would prevent possible chemotherapy, including:
- •oPlatelet count < 100/nl
- •oAbsolute neutrophil count (ANC) < 1.5/nl
- •oAST or ALT > 3 times the upper limit of normal
- •oTotal bilirubin above the normal range
- •oSerum creatinine > 1.7 mg/dl
- •Patients with clinically significant liver-, renal- or blood disorder
- •Patients with known additional significant neurological disease (e.g. primary seizure disorder*, dementia, progressive degenerative neuro-logical disease, meningitis or encephalitis, hydrocephalus with in-creased intracranial pressure)
- •*Patients with brain tumor-related epilepsy, seizure-free under antiepileptic therapy are eligible
- •Documented allergy to conductive hydrogel (e.g. ECG (electrocardio-gram) sticker or TENS (transcutaneous electrical nerve stimulation) electrodes)
- •Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts)or documented clinically significant arrhythmias
- •Skull defect (e.g. missing bone with no replacement) and bullet frag-ments in the skull
- •History of hypersensitivity reaction to temozolomide or lomustine
- •History of HIV infection
研究者
相似试验
已完成
2 期
A phase II trial of TTFields in addition to pemetrexed and cisplatin or carboplatin as first-line treatment in malignant pleural mesothelioma1002741210035597Malignant pleural mesotheliomaNL-OMON43520ovocure Ltd.27
进行中（未招募）
1 期
An early-stage clinical trial to evaluate the safety and effectiveness of GDC-0032 when given alongside Tamoxifen to patients with HER2 negative advanced breast cancer, who have previously received hormone treatmentHormone receptor positive metastatic breast cancerMedDRA version: 19.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2013-003947-51-GBKI-AV322
已完成
2 期
Phase I/prospective randomized phase II trial Of the Safety and Efficacy of tamoxifen in combination with the Isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alONe in hormone receptor positive, HER2 negative, metastatic breast cancer patients with prior exposure to endocrine treatment (POSEIDON trial)10006291breast cancerNL-OMON55501ederlands Kanker Instituut120
进行中（未招募）
1 期
An early-stage clinical trial to evaluate the safety and effectiveness of GDC-0032 when given alongside Tamoxifen to patients with HER2 negative advanced breast cancer, who have previously received hormone treatmentHormone receptor positive metastatic breast cancerMedDRA version: 20.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2013-003947-51-NLKI-AV322
招募中
1 期
Phase I study for the efficacy and the safety of the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia.interstitial pneumonia, lung cancer, metastatic lung tumor, pneumothoraxJPRN-UMIN000003295Tokyo Women's Medical University of Medicine, Department of Surgery I30