JPRN-jRCTs051180159进行中（未招募）2 期
Phase 2 trial to explore Efficacy and safety of implant gliadel for newly diagnosed GBM and reimplant gliadel for recurrent GBM - Gateway-study
Kijima Noriyuki0 个研究点目标入组 65 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
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
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •1) To have MRI within 14 days before treatment
- •2) Suspicion of GBM (grade 4) or detection of malignant gliomas by the pathological diagnosis during surgery or detection of malignant gliomas by the pathological diagnosis during surgery and diagnosis GBM by MRI before implant gliadel
- •3) Using 5-ALA when the tumor removed
- •4) To provide tissue sample
- •5) 20 to 75 years old
- •6) ECOG performance status of 0 or 1
- •7) Sufficient function of important organs. And required baseline within 4 weeks before treatment
- •Neu >= 1,500mm3
- •Plt >=75,000mm3
- •Hb >= 8g/dL
- •AST and ALT <= 3 x baseline that depends on hospital
- •Serum Bil <= 1.5 x max value that depends on hospital
- •Alb >= 3.0g/dL
- •Cr <= 1.5mg/dL
- •ECG: no abnormal condition
- •Pulmonary function: SpO2 >= 94%
- •8) No uncontrollable pleural, peritoneal or cardiac effusion
- •9) Expect survival time is 3-month and more
- •10) Written informed consent either before or after surgery(within a 14 day period)
- •1) Take MRI scan within 14 days before implant gliadel
- •2) Recurrent GBM
- •3) The best treatment that remove tumor when the GBM recurrent
- •4) Using 5-ALA when the tumor removed
- •5) To provide tissue sample
- •6) Sufficient function of important organs. And required baseline within 4 weeks before treatment
- •Neu >= 1,500mm3
- •Plt >=75,000mm3
- •Hb >= 8g/dL
- •AST and ALT <= 3 x baseline that depends on hospital
- •Serum Bil <= 1.5 x max value that depends on hospital
- •Alb >= 3.0g/dL
- •Cr <= 1.5mg/dL
- •ECG: no abnormal condition
- •Pulmonary function: SpO2 >= 94%
- •7) No uncontrollable pleural, peritoneal or cardiac effusion
- •8) Expect survival time is 3-month and more
排除标准
- •1) Multiple tumor or tumor that over median line
- •2) Serum positive for HBs antigen
- •3) High risk of fatality due to systemic disease within 12 months
- •4) Falling under any of the following
- •(1)Patients have had a tumor removed for purposes other than this study(excluding patients who have had biopsies for pathological evaluation)
- •(2) Chemotherapy before remove tumor
- •(3) Radiation therapy for brain
- •5) Treat interstitial therapy or Stereotactic Radiosurgery (SRS)
- •6) Impossible contrast-enhanced MRI
- •7) Hypersensitivity to Nitrosourea
- •8) Treated Malignancy or complication Malignancy except brain
- •9) Used gliadel or carmustine
- •10) Impossible join this study because of complications that over Grade3 provided by JCOG
- •11) Need intravenous transfusion, tube feeding or TPN within 24 hours because of alimentary canal issue and so on
- •12) Pregnant or nursing females
- •13) Serious mental disability
- •14) Other reasons for exclusion
- •1) High risk of fatality due to systemic disease within 6 months
- •2) Serum positive for HBs antigen
- •3) Impossible contrast-enhanced MRI
- •4) Treated Malignancy or complication Malignancy except brain
- •5) Impossible join this study because of complications that over Grade3 provided by JCOG
- •6) Need intravenous transfusion, tube feeding or TPN within 24 hours because of alimentary canal issue and so on
- •7) Pregnant or nursing females
- •8) Serious mental disability
- •9) Other reasons for exclusion
研究者
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