UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040599 |
|---|---|
| Receipt number | R000046330 |
| Scientific Title | Multicombination Therapy of Temozolomide, Vincristine, and Interferon-beta with Radiotherapy for Malignant Glioma |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2020/06/01 00:27:42 |
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Basic information
Public title
Multicombination Therapy of Temozolomide, Vincristine, and Interferon-beta with Radiotherapy for Malignant Glioma
Acronym
R-TVI trial
Scientific Title
Multicombination Therapy of Temozolomide, Vincristine, and Interferon-beta with Radiotherapy for Malignant Glioma
Scientific Title:Acronym
R-TVI trial
Region
| Japan |
Condition
Condition
Malignant glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Multicombination therapy with the radiation containing temozolomide(TMZ) alternated from ACNU which commonly used in daily clinical practice as community standard chemotherapy has not studied in Japan. As TMZ has proved advantage compared with another alkylating agents, this novel combination therapy would be effective. So, the aim of this study is to prove efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2y-OS
Key secondary outcomes
Progression free survival: PFS
5y-OS
Overall survival: OS
PFS and OS with MGMT methylation status
Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initial therapy:
Temozolomide (75mg/m2/day), Day 1 to 45, po
Vincristine (0.6mg/m2), Day2 and 3, iv
IFN-beta (3MIU/body/day), 3 days/week, DIV, during radiotherapy
Radiotherapy (60 Gy/30 fr), 5 days/week
Maintenance therapy:
Temozolomide (100-200mg/m2/day), Day1-5/month, po. At least 24C, Max 50C
IFN-beta (3 MIU/body), day1/week, DIV
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) For patients who undergo surgery for first relapse disease with histologically proven malignant glioma and could accept informed consent
2) Age is 16~80 yo
3) Tumor location is in supra-tentorial lesion without optic nerve, hypothalamus, brain stem and dissemination
4) Without experience of chemo-radiotherapy for other malignant tumor
5) Without past history of RT
6) Without double cancer
7) Eastern Cooperative Oncology Group(ECOG) performance scale(PS) 0-2 or PS3 with neurological deficit
8) With normal organic function
9) Without severe infection
10) This protocol would be able to start within 21 days
11) The rate of operation removal is not concern
Key exclusion criteria
Patients who did not satisfy inclusion criteria
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Asano |
Organization
Hirosaki University School of Medicine
Division name
Department of Neurosurgery
Zip code
036-8562
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, 036-8562, Japan
TEL
0172-39-5115
asanoken@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Asano |
Organization
Hirosaki University School of Medicine
Division name
Department of Neurosurgery
Zip code
036-8562
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, 036-8562, Japan
TEL
0172-39-5115
Homepage URL
asanoken@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Hirosaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Hirosaki University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Committee of Medical Ethics of Hirosaki University Graduate School of Medicine,Hirosaki,Japan
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, 036-8562, Japan
Tel
0172-33-5111
jm5194@hirosaki-u.ac.jp
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
| 2020 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
http://www.med.hirosaki-u.ac.jp/~neuros/
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Manuscript of this study is now submitting. However, it is not accepted.
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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2008 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 30 | Day |
Other
Other related information
This study was approved by The Committee of Medical Ethics of Hirosaki University Graduate School of Medicine, Hirosaki, Japan (Approved No 2007-142)
Management information
Registered date
| 2020 | Year | 05 | Month | 31 | Day |
Last modified on
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046330
