UMIN-CTR Clinical Trial

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
Email	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
Email	asanoken@hirosaki-u.ac.jp

Sponsor
Institute	Department of Neurosurgery, Hirosaki University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046330