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

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 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


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

Value
https://center6.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