UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019596 |
|---|---|
| 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 |
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Basic information
Public title
Phase II study of implantation of carmustine wafers, followed by radiation therapy and concomitant temozolomide and bevacizumab for newly diagnosed glioblastoma.
Acronym
RADICAL TRIAL (PHASE II TRIAL OF CARMUSTINE WAFERS, IRRADIATION, BEVACIZUMAB AND TEMOZOLOMIDE FOR TOTALLY RESECTED GLIOBLASTOMA)
Scientific Title
Phase II study of implantation of carmustine wafers, followed by radiation therapy and concomitant temozolomide and bevacizumab for newly diagnosed glioblastoma.
Scientific Title:Acronym
RADICAL TRIAL (PHASE II TRIAL OF CARMUSTINE WAFERS, IRRADIATION, BEVACIZUMAB AND TEMOZOLOMIDE FOR TOTALLY RESECTED GLIOBLASTOMA)
Region
| Japan |
Condition
Condition
Newly diagnosed glioblastoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-year overall survival rate
Key secondary outcomes
Overall survival time
Progression-free survival time
Local recurrence-free survival time
KPS deterioration free survival time
Adverse events
Severe adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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)
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teiji Tominaga |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL
+81-22-717-7230
tomi@nsg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Kanamori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL
+81-22-717-7230
Homepage URL
mkanamori@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Eisai, Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2018 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022618
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