UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002434
Receipt number R000002979
Scientific Title A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS
Date of disclosure of the study information 2010/01/01
Last modified on 2016/09/07 09:12:47

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Basic information

Public title

A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

Acronym

A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

Scientific Title

A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

Scientific Title:Acronym

A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

Region

Japan North America Australia
Europe


Condition

Condition

Glioblastoma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the overall survival rates between short-course radiation therapy alone and short-course radiation therapy given together with concurrent and adjuvant temozolomide, in elderly (>=65 years of age) patients with newly diagnosed glioblastoma multiforme.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Progression-free survival
Adverse events
Quality of life


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

radiotherapy

Interventions/Control_2

temozolomide

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Histopathologically confirmed newly diagnosed glioblastoma multiforme
Patient's age is > 65 years.

Key exclusion criteria

Patients with a history of other malignancies.
Patients with a serious active infection at the time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment.
Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide.
Patients who have had treatment with any investigational cancer drug prior to randomization.

Target sample size

560


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryo Nishikawa

Organization

International Medical Center, Saitama Medical University

Division name

Department of Neuro-Oncology

Zip code


Address

1397-1 Yamane, Hidaka-shi, Saitama-ken 350-1298, Japan

TEL

042-984-4111

Email

rnishika@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryo Nishikawa

Organization

International Medical Center, Saitama Medical University

Division name

Department of Neuro-Oncology

Zip code


Address

1397-1 Yamane, Hidaka-shi, Saitama-ken 350-1298, Japan

TEL

042-984-4111

Homepage URL


Email

rnishika@saitama-med.ac.jp


Sponsor or person

Institute

National Cancer Institute of Canada

Institute

Department

Personal name



Funding Source

Organization

National Cancer Institute of Canada

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Canada


Other related organizations

Co-sponsor

MICRON

Name of secondary funder(s)

Schering-Plough K.K.


IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

CE.6

Org. issuing International ID_1

National Cancer Institute of Canada

Study ID_2

26062-22061

Org. issuing International ID_2

EORTC

IND to MHLW



Institutions

Institutions

埼玉医科大学国際医療センター(埼玉県)
広島大学付属病院(広島県)


Other administrative information

Date of disclosure of the study information

2010 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2007 Year 04 Month 16 Day

Date of IRB


Anticipated trial start date

2009 Year 10 Month 01 Day

Last follow-up date

2014 Year 04 Month 01 Day

Date of closure to data entry

2014 Year 04 Month 01 Day

Date trial data considered complete

2015 Year 04 Month 01 Day

Date analysis concluded

2015 Year 11 Month 20 Day


Other

Other related information



Management information

Registered date

2009 Year 09 Month 02 Day

Last modified on

2016 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name