Unique ID issued by UMIN | UMIN000019596 |
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Receipt number | R000022618 |
Scientific Title | Phase II study of implantation of carmustine wafers, followed by radiation therapy and concomitant temozolomide and bevacizumab for newly diagnosed glioblastoma. |
Date of disclosure of the study information | 2016/01/14 |
Last modified on | 2018/05/05 09:07:44 |
Phase II study of implantation of carmustine wafers, followed by radiation therapy and concomitant temozolomide and bevacizumab for newly diagnosed glioblastoma.
RADICAL TRIAL (PHASE II TRIAL OF CARMUSTINE WAFERS, IRRADIATION, BEVACIZUMAB AND TEMOZOLOMIDE FOR TOTALLY RESECTED GLIOBLASTOMA)
Phase II study of implantation of carmustine wafers, followed by radiation therapy and concomitant temozolomide and bevacizumab for newly diagnosed glioblastoma.
RADICAL TRIAL (PHASE II TRIAL OF CARMUSTINE WAFERS, IRRADIATION, BEVACIZUMAB AND TEMOZOLOMIDE FOR TOTALLY RESECTED GLIOBLASTOMA)
Japan |
Newly diagnosed glioblastoma
Neurosurgery |
Malignancy
NO
To verify the safety and efficacy of implantation of carmustine wafers, followed by radiation therapy and concomitant temozolomide and bevacizumab for totally resected newly diagnosed glioblastoma.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
2-year overall survival rate
Overall survival time
Progression-free survival time
Local recurrence-free survival time
KPS deterioration free survival time
Adverse events
Severe adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Implantation of BCNU wafers (maximum 8 wafers)
Radiation therapy (local site, 60Gy, 30 fractions)
Temozolomide (concomitant phase: 75mg/m2, maintenance phase: 150-200mg/m2, 6 dose)
Bevacizumab (10mg/kg, starting at week 4 of radiotherapy, 15 doses)
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Temporal registration
1) No prior treatment for glioma.
2) Preoperative MRI suggests that the lesion is glioblastoma, and total resection of the enhanced lesion is possible.
3) No systemic metastatic lesions.
4) More than or equal to 50% of tumor must be located in cerebrum or diencephalon.
5) No multicentric lesions, dissemination, nor invasion to optic, olfactory nerve, or pituitary gland.
6) Age must be >= 20 and <= 75 years old.
7) Written informed consent must be provided.
Definitive registration
1) Histologically verified glioblastoma based on WHO classification.
2) Planning target volume must be less than one- third of volume of cerebrum and diencephalon.
3) There must be no measurable lesion on MR images obtained within 72 hours after resection.
4) Patients must be registered >= 3 days and <= 20 days after resection.
5) ECOG PS must be 0-2, and 3 due to neurological symptoms caused by tumor.
6) Adequate bone marrow, hepatic, renal, coagulation function.
1) Evidence of recent and progressive or symptomatic intracranial hemorrhage on the postoperative MRI.
2) Prior chemotherapy, radiotherapy, or immunotherapy for cancer of other organ.
3) Prior radiotherapy to the brain for the lesion other than glioma.
4) Uncontrolled hypertension (systolic pressure >= 150, diastolic pressure >= 100).
5) History of hypertensive crisis, 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) Pregnant or women of childbearing potential and men who are sexually active and not willing to use medically acceptable forms of contraception. Lactating women are not permissible.
14) Allergy to temozolomide, carmustine, bevacizumab
15) Contraindication of gadolinium contrast agent due to allergy or other reasons.
16) Patients registering other clinical trial.
17) Any other medical or psychiatric impairments that will prevent administration of protocol therapy in the investigator opinion.
47
1st name | |
Middle name | |
Last name | Teiji Tominaga |
Tohoku University Graduate School of Medicine
Department of Neurosurgery
1-1 Seiryo-cho, Aoba-ku, Sendai, Japan
+81-22-717-7230
tomi@nsg.med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Masayuki Kanamori |
Tohoku University Graduate School of Medicine
Department of Neurosurgery
1-1 Seiryo-cho, Aoba-ku, Sendai, Japan
+81-22-717-7230
mkanamori@med.tohoku.ac.jp
Tohoku University
Eisai, Co., Ltd
Profit organization
NO
2016 | Year | 01 | Month | 14 | Day |
Unpublished
No longer recruiting
2015 | Year | 11 | Month | 10 | Day |
2016 | Year | 01 | Month | 10 | Day |
2020 | Year | 10 | Month | 31 | Day |
2015 | Year | 11 | Month | 02 | Day |
2018 | Year | 05 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022618
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