UMIN-CTR Clinical Trial

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

Elderly glioblastoma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall survival

Key secondary outcomes

Progression-free survival, Response Rate, Toxicity, QOL

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name

Organization

Saitama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

10

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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