Unique ID issued by UMIN | UMIN000026856 |
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Receipt number | R000028792 |
Scientific Title | Phase 2 study of bevacizumab in a fixed term for glioblastoma |
Date of disclosure of the study information | 2017/04/04 |
Last modified on | 2017/07/20 09:46:28 |
Phase 2 study of bevacizumab in a fixed term for glioblastoma
Study of bevacizumab in a fixed term for glioblastoma
Phase 2 study of bevacizumab in a fixed term for glioblastoma
Study of bevacizumab in a fixed term for glioblastoma
Japan |
glioblastoma
Neurosurgery |
Malignancy
YES
To evaluate the efficacy and safety of bevacizumab in a fixed term for glioblastoma
Safety,Efficacy
Exploratory
Pragmatic
Phase II
progression free survival, time of high KPS
overall survival, 2-year survival rate, the rae of adverse events, the rate of severe adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Radiation therapy (local site, 60Gy, 30 fractions)
Temozolomide (concomitant phase: 75mg/m2, maintenance phase: 150-200mg/m2)
Bevacizumab (10mg/kg, starting at week 4 of radiotherapy, 12 doses)
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Histologically verified glioblastoma based on WHO classification.
(1) No prior treatment for glioma.
(2) initial glioma
(3) tumor was resected more than 90 % based on postoperative MRI
(4) More than or equal to 50% of tumor must be located in cerebrum or diencephalon.
(5) clinically no metastatic tumors
(6) No multicentric lesions nor dissemination on preoperative MRI.
(7) ECOG PS must be 0-2, and 3 due to neurological symptoms caused by tumor.
(8) Age must be >= 20 and <= 75 years old.
(9) Written informed consent must be provided.
(10)meet the criteria shown below.
The latest results should be adopted.
1) neutrophil count >=1,500/mm3
2) Haemoglobin >=8.0g/dL
3) Platelet count >=10.0*the fourth power of10/mm3
4) AST <=120IU/L
5) ALT <=120IU/L
6) Serum creatinine <=1.5mg/dL
7) Proteinuria <=1+
8) PT-INR <=1.5
(1) Evidence of recent haemorrhage on postoperative MRI.
(2) Any prior chemotherapy, radiotherapy or immunotherapy (including vaccine therapy) for glioma.
(3) Prior radiotherapy to the brain.
(4) Uncontrolled hypertension (systolic pressure >= 150, diastolic pressure >= 100).
(5)Prior history of hypertensive crisis, or hypertensive encephalopathy.
(6)Congestive heart failure (NYHA class III, or greater)
(7)History of hemoptysis (Grade 2 or higher in CTCAE v4.0) within 1 month.
(8) Coagulopathy
(9) Uncontrolled gastrointestinal ulceration.
(10) Serious or non-healing wound or traumatic bone fracture.
(11) Past history within 6 months, as follows.
Unstable angina, acute myocardial infarction, symptomatic cerebral infarction, arterial or venous thrombosis which required medical treatment, digestive tract perforation or abdominal fistula,intra-abdominal abscess, and intracranial abscess
(12) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
(13) Pregnancy or lactation, as well as fertile women and men unwilling or unable to use effective means of contraception
(14) Allergy to temozolomide, bevacizumab
(15) Patients with allergy to gadolinium.
(16) Patients registering other clinical trial.
(17) Attending physician has determined unsuitable to participate in the study.
10
1st name | |
Middle name | |
Last name | Yuichi Hirose |
Fujita Health University
Department of Neurosurgery
1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
0562-93-9253
shigeo.ohba@gmail.com
1st name | |
Middle name | |
Last name | Shigeo Ohba |
Fujita Health University
Department of Neurosurgery
1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi
0562-93-9253
shigeo.ohba@gmail.com
Fujita Health University
none
Self funding
NO
2017 | Year | 04 | Month | 04 | Day |
Unpublished
Open public recruiting
2016 | Year | 09 | Month | 28 | Day |
2017 | Year | 04 | Month | 03 | Day |
2017 | Year | 04 | Month | 04 | Day |
2017 | Year | 07 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028792
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