UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024209
Receipt No. R000027858
Scientific Title The therapeutic effect ofTemozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The therapeutic effect ofTemozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
Acronym The therapeutic effect of Temozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
Scientific Title The therapeutic effect ofTemozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
Scientific Title:Acronym The therapeutic effect of Temozolomide, Vincristine, Interferon-beta and Bevacizumab Combination Chemoradiotherapy for Malignant Gliomas
Region
Japan

Condition
Condition Malignant glioma
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate efficacy and safety of temozolomide, vincristine, interferon-beta with radiotherapy, plus bevacizumab for malignant gliomas.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes progression-free survival, 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 Initial therapy:

Temozolomide (75mg/m2/day, administered orally everyday from day 1 to day 45)
Vincristine (0.6mg/m2, Day2 and 3 div)
IFN-beta (3 MIU/body/day, administered intravenously 3 days/week during radiotherapy)
Radiotherapy (60 Gy/30 fr, 5 days/week)
Bevacizumab (10 mg/kg, day 1 div, every 2 weeks)

Maintenance therapy:
Temozolomide (100-200mg/m2/day, da1-5, every 4 weeks)
IFN-beta (3 MIU/body, day1 div, every week)
Bevacizumab (10 mg/kg, day 1 div, every 2 weeks)
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; (i)histologically proven diagnosis of malignant glioma ; (ii)sufficient organ functions; (iii)written informed consent.
2. For patients who undergo surgery for recurrent disease; (i)histologically proven diagnosis of malignant glioma ; (ii)prior treatment for newly-diagnosed malignant glioma without postoperative radiotherapy; (iii)sufficient organ functions; (iv)written informed consent.
3. For patients who undergo surgery for recurrent disease; (i)histologically proven diagnosis of malignant glioma ; (ii)prior treatment for newly-diagnosed malignant glioma with postoperative radiotherapy; (iii)sufficient organ functions; (iv)written informed consent.
4. For patients who did not undergo surgery for first relapse disease; (i)clinically proven diagnosis of malignant glioma ; (ii)sufficient organ functions; (iii)written informed consent.
Key exclusion criteria Patients who did not satisfy inclusion criteria.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ohkuma
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address Zaifu-cho 5, Hirosaki-shi, Aomori 036-8562
TEL 0172-39-5115
Email nougeka@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichiro Asano
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address Zaifu-cho 5, Hirosaki-shi, Aomori 036-8562
TEL 0172-39-5115
Homepage URL
Email nougeka@hirosaki-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Hirosaki University Graduate school of Medicine
Institute
Department

Funding Source
Organization Department of Neurosurgery, Hirosaki University Graduate 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
Address
Tel
Email

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 10 Month 01 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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 28 Day
Last modified on
2016 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027858

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.