UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017683 |
|---|---|
| Receipt number | 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 14:07:53 |
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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
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
gateway-study@inc-re.com
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020497
