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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017683
Receipt No. R000020497
Scientific Title Phase 2 trial to explore Efficacy and safety of implant gliadel for newly diagnosed GBM and reimplant gliadel for recurrent GBM
Date of disclosure of the study information 2015/05/27
Last modified on 2016/07/01

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Basic information
Public title Phase 2 trial to explore Efficacy and safety of implant gliadel for newly diagnosed GBM and reimplant gliadel for recurrent GBM
Acronym Gateway-study
Scientific Title Phase 2 trial to explore Efficacy and safety of implant gliadel for newly diagnosed GBM and reimplant gliadel for recurrent GBM
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Naoki Kagawa
Organization Osaka University Graduate school of Medicine
Division name Neurosurgery
Zip code
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
1st name
Middle name
Last name Re Co., Ltd
Organization Re Co., Ltd
Division name Gateway study office
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 04 Month 09 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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