Phase 2 trial to explore Efficacy and safety of implant gliadel for newly diagnosed GBM and reimplant gliadel for recurrent GBM - Gateway-study

Osaka University0 个研究点目标入组 65 人开始时间: 2015年5月27日最近更新: 2023年10月17日

试验速览

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•Stage1 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 Other reasons for exclusion Stage2 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 Other reasons for exclusion

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