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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012172
Receipt No. R000014210
Scientific Title Multicenter phase2 clinical trial of tailored therapy according to MGMT methylation status for elderly glioblastoma patients
Date of disclosure of the study information 2013/10/30
Last modified on 2013/10/30

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Basic information
Public title Multicenter phase2 clinical trial of tailored therapy according to MGMT methylation status for elderly glioblastoma patients
Acronym Multicenter phase2 clinical trial of tailored therapy according to MGMT methylation status for elderly glioblastoma patients(EGG trial)
Scientific Title Multicenter phase2 clinical trial of tailored therapy according to MGMT methylation status for elderly glioblastoma patients
Scientific Title:Acronym Multicenter phase2 clinical trial of tailored therapy according to MGMT methylation status for elderly glioblastoma patients(EGG trial)
Region
Japan

Condition
Condition Elderly glioblastoma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of tailored therapy according to MGMT promotor methylation status (temozolomide therapy for methylated MGMT cases, radiation therapy for unmethylated MGMT cases)
for elderly glioblastoma patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival
Key secondary outcomes Progression-free survival, Response Rate, Toxicity, QOL

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 temozolomide therapy for methylated MGMT cases, radiation therapy for unmethylated MGMT cases
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade 4). The histological diagnosis must have been made after biopsy or neurosurgical tumour resection
2) Initial surgery/biopsy at diagnosis performed within 4 weeks (28 days) prior to registration.
3) 70 years or older
4) Karnofsky performance status 60 or higher
5) Patient has not received prior chemotherapy or radiotherapy.
6) Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to registration
Absolute granulocyte count above 1.5 x 109/L
Platelet count above 100x109/L
ALT (GPT) 100 IU/L or under
AST (GOT) 100 IU/L or under
Total serum bilirubin 1.5 mg/dL or under
Serum creatinine 1.5 mg/dL or under
7) Written informed consent
8) Protocol treatment is to begin within 3 weeks of MGMT status determination.
Key exclusion criteria 1) Previous or concurrent cancer within 5 years, excluding carcinoma in situ, skin cancers except melanoma which was curatively treated
2) Infectious disease requiring systemic treatment
3) Psychotic disorder
4) hepatitis B virus carrier
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Nishikawa
Organization Saitama Medical University International Medical Center
Division name Department of Neuro-Oncology
Zip code
Address 1397-1 yamane Hidaka-shi, Saitama, Japan.
TEL 042-984-4111
Email rnishika@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuaki Shirahata
Organization Saitama Medical University International Medical Center
Division name Department of Neuro-Oncology
Zip code
Address 1397-1 yamane Hidaka-shi, Saitama, Japan.
TEL 042-984-4111
Homepage URL
Email misrht@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 10 Month 30 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
2013 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 20 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
2013 Year 10 Month 30 Day
Last modified on
2013 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014210

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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