JPRN-jRCT2032230060招募中2 期
Multicenter, phase II trial of Tumor Treatment Fields system in patients with newly diagnosed IDH-wildtype lower-grade glioma - Multicenter, phase II trial of Tumor Treatment Fields system in patients with newly diagnosed IDH-wildtype lower-grade glioma
Tanaka Shota0 个研究点目标入组 50 人开始时间: 2023年4月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •At the time of enrollment, patients will be included if they meet all of the following criteria.
- •1) Diagnosis of IDH wild-type glioma (grade III) (anaplastic astrocytoma) *after tumor resection or biopsy.
- •*According to the WHO Classification of Brain Tumors, Fourth Revision (2016)
- •2) No history of surgical treatment for glioma (first case), except for resection or biopsy. However, if a second surgery (excision) is performed on the residual lesion within 28 days of the first surgery (excision or biopsy), the patient is eligible.
- •3) Implantation of carmustine intracerebroventricularly at the time of surgery is acceptable.
- •4) Preoperative contrast-enhanced MRI of the head shows tumor only supratentorial (not in the brainstem or cerebellum).
- •5) No evidence of disseminated lesions on contrast-enhanced MRI of the head prior to enrollment.
- •6) Can be registered regardless of the presence or absence of measurable lesions prior to enrollment.
- •7) Radiation therapy with temozolomide (TMZ) is the initial treatment.
- •Radiotherapy is administered for more than 50 Gy in the initial treatment and TMZ in combination with radiotherapy is administered for more than 30 days.
- •8) Within 49 days of the last day of radiation therapy with TMZ
- •9) Age 18 years or older on the date consent is obtained.
- •10)Karnofsky performance status (KPS) more than equal 70
- •11) No prior chemotherapy or radiation therapy for other types of cancer. However, prior endocrine therapy (hormone therapy for breast cancer, hormone therapy for prostate cancer) is eligible.
- •12) All of the following conditions are met. All laboratory tests should be the most recent within 14 days before registration.
- •(1) Neutrophil Counts>=1,500 /mm3
- •(2) Hemoglobin>=8.0 g/dL
- •(3) Platelet Counts>=10 *10,000/mm3
- •(4)AST(GOT)<=120 U/L
- •(5)ALT(GPT)<=120 U/L
- •(6)Creatinine<=1.5 mg/dL
- •13) Expected to survive at least 12 weeks from the date of registration
- •14) Can use effective contraceptive methods (if of childbearing age)
- •15) The patient's free written consent to participate in this clinical trial has been obtained after receiving a full explanation of the study (no surrogate consent is acceptable).
排除标准
- •Any of the following conditions shall not apply
- •1) Have active overlapping cancers(Simultaneous overlapping/multiple cancers and iatrogenic overlapping/multiple cancers with a disease-free interval of 5 years or less. However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included in active multiple/multiple cancers.)
- •2) Has an infection requiring systemic treatment
- •3) Complicated infectious meningitis requiring treatment
- •4) Fever greater than 38 degree Celsius at axillary temperature at the time of registration
- •5) Delayed wound healing after excision or biopsy
- •6) Patients with implanted medical devices that are contraindicated, such as pacemakers, defibrillators, or deep brain stimulators
- •7) Pregnant, possibly pregnant, or breastfeeding women
- •8) Psychosis or psychiatric comorbidities that would make participation in the study difficult
- •9) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive agents for diseases other than brain tumors. Steroids for brain tumors are acceptable
- •10) Complicated unstable angina (angina with onset or worsening of attacks within 3 weeks prior to enrollment), or history of myocardial infarction within 6 months
- •11) Pulmonary fibrosis, interstitial pneumonia, or severe emphysema as diagnosed by chest x-ray, or with one or more of the following
- •12) Gadolinium is not available due to drug allergy
- •13) HIV antibody is positive
- •14) HBs antigen is positive
- •15) Participating in another clinical trial
- •16) Other conditions that the investigator or subinvestigator considers inappropriate for participation in this study
研究者
相似试验
进行中（未招募）
不适用
Avelumab (MSB0010718C) in Subjects With Merkel Cell CarcinomaMerkel Cell CarcinomaEUCTR2014-000445-79-ATMerck KGaA84
进行中（未招募）
不适用
MSB0010718C in Subjects With Skin CancerMerkel Cell CarcinomaMedDRA version: 17.0Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 100000004864EUCTR2014-000445-79-ITMerck KGaA84
进行中（未招募）
1 期
Avelumab in Subjects With Merkel Cell CarcinomaMerkel Cell CarcinomaEUCTR2014-000445-79-DEMerck KGaA200
进行中（未招募）
1 期
MSB0010718C in Subjects With Skin CancerMedDRA version: 17.1Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 100000004864Merkel Cell CarcinomaEUCTR2014-000445-79-ESMerck KGaA84
招募中
2 期
Cancer Molecular Screening and Therapeutics (MoST) Program and ASPiRATION subprogram, Addendum 14 – substudy 32: AlectinibALK gene alterationsCancer - Any cancerCancer - Lung - Non small cellNon-small cell lung cancerCancerACTRN12621000312842niversity of Sydney16