Newly Diagnosed GBM
Conditions
Interventions
Implant gliadel for newly diagnosed Glioblastomas after operate. Combination therapy (temodar and radiation). Maintenance therapy (temodar). Reimplant gliadel for recurrent GBM after operate. Main
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage1 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 Written informed consent either before or after surgery(within a 14 day period) Stage2 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage1:Progression Free Survival percentage for 12 months Stgae2:Overall Survival, rate of AE | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage1:Overall Survival, rate of AE | — |
Countries
Japan
Contacts
Public ContactRe Co., Ltd
Re Co., Ltd Gateway study office
Outcome results
None listed