NCT00704808已完成不适用
Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
研究概览
简要总结
The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor <=1.5 cm by magnetic resonance imaging (MRI).
- •Age >=18 years.
- •Hemoglobin >=10 g/dL.
- •White blood cell count >=1.5x10^9/L.
- •Platelet count >=100x10^9/L.
- •Blood urea <=1.5 x upper limit of normal values (ULN).
- •Creatinine <=1.5 x ULN.
- •Bilirubin <=1.5 x ULN.
- •Aspartate aminotransferase <=3 x ULN.
- •Alanine aminotransferase <=3 x ULN.
- •Alkaline phosphatase <=2 x ULN.
排除标准
- •Tumor-specific pretreatment.
- •Contraindication against radiotherapy and/or chemotherapy.
- •Malignomas other than basaliomas.
- •Existing or planned pregnancy or lactation or inadequate contraception.
- •Psychiatric disease.
- •Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.
研究组 & 干预措施
Patients
Patients with newly diagnosed and operated glioblastoma multiforme.
干预措施: Primary surgical treatment (Procedure)
Patients
Patients with newly diagnosed and operated glioblastoma multiforme.
干预措施: Radiotherapy (Radiation)
Patients
Patients with newly diagnosed and operated glioblastoma multiforme.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
时间窗: After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Lyrica (Pregabalin) Korean Post Marketing Surveillance StudyNeuropathic PainPost-market SurveillanceEpilepsyFibromyalgiaNCT01220180Pfizer's Upjohn has merged with Mylan to form Viatris Inc.4,175
终止
不适用
An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG®Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALLNCT02455024Ariad Pharmaceuticals3
招募中
不适用
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac ArrhythmiasNCT04750798Biosense Webster, Inc.8,000
已完成
不适用
Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic DrugEpilepsies, PartialNCT01098162UCB Pharma GmbH576
招募中
不适用
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP ProductsCardiac ArrhythmiaNCT05560958Biotronik SE & Co. KG280