Unique ID issued by UMIN | UMIN000024209 |
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Receipt number | R000027858 |
Scientific Title | The therapeutic effect ofTemozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2016/09/28 19:52:41 |
The therapeutic effect ofTemozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
The therapeutic effect of Temozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
The therapeutic effect ofTemozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
The therapeutic effect of Temozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
Japan |
Malignant glioma
Radiology | Neurosurgery |
Malignancy
NO
The aim of this study is to evaluate efficacy and safety of temozolomide, vincristine, interferon-beta with radiotherapy, plus bevacizumab for malignant gliomas.
Safety,Efficacy
Exploratory
Phase II
overall survival
progression-free survival, adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Initial therapy:
Temozolomide (75mg/m2/day, administered orally everyday from day 1 to day 45)
Vincristine (0.6mg/m2, Day2 and 3 div)
IFN-beta (3 MIU/body/day, administered intravenously 3 days/week during radiotherapy)
Radiotherapy (60 Gy/30 fr, 5 days/week)
Bevacizumab (10 mg/kg, day 1 div, every 2 weeks)
Maintenance therapy:
Temozolomide (100-200mg/m2/day, da1-5, every 4 weeks)
IFN-beta (3 MIU/body, day1 div, every week)
Bevacizumab (10 mg/kg, day 1 div, every 2 weeks)
16 | years-old | <= |
80 | years-old | > |
Male and Female
1. For patients who undergo surgery for first relapse disease; (i)histologically proven diagnosis of malignant glioma ; (ii)sufficient organ functions; (iii)written informed consent.
2. For patients who undergo surgery for recurrent disease; (i)histologically proven diagnosis of malignant glioma ; (ii)prior treatment for newly-diagnosed malignant glioma without postoperative radiotherapy; (iii)sufficient organ functions; (iv)written informed consent.
3. For patients who undergo surgery for recurrent disease; (i)histologically proven diagnosis of malignant glioma ; (ii)prior treatment for newly-diagnosed malignant glioma with postoperative radiotherapy; (iii)sufficient organ functions; (iv)written informed consent.
4. For patients who did not undergo surgery for first relapse disease; (i)clinically proven diagnosis of malignant glioma ; (ii)sufficient organ functions; (iii)written informed consent.
Patients who did not satisfy inclusion criteria.
50
1st name | |
Middle name | |
Last name | Hiroki Ohkuma |
Hirosaki University Graduate School of Medicine
Department of Neurosurgery
Zaifu-cho 5, Hirosaki-shi, Aomori 036-8562
0172-39-5115
nougeka@hirosaki-u.ac.jp
1st name | |
Middle name | |
Last name | Kenichiro Asano |
Hirosaki University Graduate School of Medicine
Department of Neurosurgery
Zaifu-cho 5, Hirosaki-shi, Aomori 036-8562
0172-39-5115
nougeka@hirosaki-u.ac.jp
Department of Neurosurgery, Hirosaki University Graduate school of Medicine
Department of Neurosurgery, Hirosaki University Graduate school of Medicine
Self funding
NO
2016 | Year | 10 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 04 | Month | 01 | Day |
2016 | Year | 09 | Month | 28 | Day |
2016 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027858
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