UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 trial to explore Efficacy and safety of implant gliadel for newly diagnosed GBM and reimplant gliadel for recurrent GBM
Title of the study (Brief title)	Gateway-study
Region	Japan

Condition
Condition	Newly Diagnosed GBM
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To explore to Efficacy and safety of implant gliadel for newly diagnosed GBM and reimplant gliadel for recurrent GBM. Test MGMT Promoter Methylation from removed tumor. To evaluate prognosis and after treatment even if the recurrent GBM that dosen't operate.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Stage1:Progression Free Survival percentage for 12 months Stgae2:Overall Survival, rate of AE
Key secondary outcomes	Stage1:Overall Survival, rate of AE

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Implant gliadel for newly diagnosed Glioblastomas after operate. Combination therapy (temodar and radiation). Maintenance therapy (temodar). Reimplant gliadel for recurrent GBM after operate. Maintenance therapy (avastin).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	65

Research contact person
Name of lead principal investigator	Naoki Kagawa
Organization	Osaka University Graduate school of Medicine
Division name	Neurosurgery
Address	15-2 yamadaoka, suita City, Osaka, Japan
TEL	06-6879-3652
Email	nhashimoto@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Re Co., Ltd
Organization	Re Co., Ltd
Division name	Gateway study office
Address	4F Hoei Fuchu Building, 2-10-3 Kotobukicho, Fuchu-shi, Tokyo
TEL	042-367-2306
Homepage URL
Email	gateway-study@inc-re.com

Sponsor
Institute	Osaka University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Eisai Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 09 Day
Anticipated trial start date	2015 Year 04 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 26 Day
Last modified on	2016 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020497