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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002434
Receipt No. 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

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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
Institute National Cancer Institute of Canada
Institute
Department

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
URL(English) https://upload.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


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