UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Ryo Nishikawa
Organization	International Medical Center, Saitama Medical University
Division name	Department of Neuro-Oncology
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	Ryo Nishikawa
Organization	International Medical Center, Saitama Medical University
Division name	Department of Neuro-Oncology
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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 04 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000002979