Unique ID issued by UMIN | UMIN000002434 |
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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 |
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
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
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
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
Japan | North America | Australia |
Europe |
Glioblastoma
Neurosurgery |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Phase III
Overall survival
Progression-free survival
Adverse events
Quality of life
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
2
Treatment
Medicine |
radiotherapy
temozolomide
65 | years-old | <= |
Not applicable |
Male and Female
Histopathologically confirmed newly diagnosed glioblastoma multiforme
Patient's age is > 65 years.
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.
560
1st name | |
Middle name | |
Last name | Ryo Nishikawa |
International Medical Center, Saitama Medical University
Department of Neuro-Oncology
1397-1 Yamane, Hidaka-shi, Saitama-ken 350-1298, Japan
042-984-4111
rnishika@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Ryo Nishikawa |
International Medical Center, Saitama Medical University
Department of Neuro-Oncology
1397-1 Yamane, Hidaka-shi, Saitama-ken 350-1298, Japan
042-984-4111
rnishika@saitama-med.ac.jp
National Cancer Institute of Canada
National Cancer Institute of Canada
Outside Japan
Canada
MICRON
Schering-Plough K.K.
YES
CE.6
National Cancer Institute of Canada
26062-22061
EORTC
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)
2010 | Year | 01 | Month | 01 | Day |
Published
Completed
2007 | Year | 04 | Month | 16 | Day |
2009 | Year | 10 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 11 | Month | 20 | Day |
2009 | Year | 09 | Month | 02 | Day |
2016 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002979
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