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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046330


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name