UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012172 |
|---|---|
| Receipt number | 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 19:33:38 |
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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
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
misrht@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014210
