UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015566
Receipt number R000018089
Scientific Title Phase I study of neo-adjuvant chemoradiation therapy for newly diagnosed malignant astrocytomas
Date of disclosure of the study information 2014/11/01
Last modified on 2020/05/03 10:49:47

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Basic information

Public title

Phase I study of neo-adjuvant chemoradiation therapy for newly diagnosed malignant astrocytomas

Acronym

neoadjuvant chemoradiation for malignant astrocytomas

Scientific Title

Phase I study of neo-adjuvant chemoradiation therapy for newly diagnosed malignant astrocytomas

Scientific Title:Acronym

neoadjuvant chemoradiation for malignant astrocytomas

Region

Japan


Condition

Condition

malignant astyrocytomas

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the safety and efficacy of neo-adjuvant cheomoradiation therapy for newly diagnosed malignant astrocytomas

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Occurrence of adverse events until 12 weeks after treatment

Key secondary outcomes

progression-free survival, overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment Maneuver

Interventions/Control_1

day 1-30 Temozolomide 75mg/m2, once daily
day 15-30 IMRT 6.0Gy x 12 fractions
day 37 surgical removal

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

clinically diagnosed malignant astrocytomas
no evidence of CSF dissemination
visible on MRI
normal bone marrow, liver, and renal function
written informed consent

Key exclusion criteria

large tumor (>6cm)
sign of tent-herniation
existence of extracranial malignant tumor
pregnancy
psychological disorder
HIV positive patients
history of pneumonitis
history of radiation therapy for intracranial lesions

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Toshihiko
Middle name
Last name Iuchi

Organization

Chiba Cancer Center

Division name

Division of Neurological Surgery

Zip code

2608717

Address

666-2 Nitona-cho, Chuo-ku, Chiba, Japan

TEL

043-264-5431

Email

tiuchi@chiba-cc.jp


Public contact

Name of contact person

1st name Toshihiko
Middle name
Last name Iuchi

Organization

Chiba Cancer Center

Division name

Division of Neurological Surgery

Zip code

260-8717

Address

666-2 Nitona-cho, Chuo-ku, Chiba, Japan

TEL

043-264-5431

Homepage URL


Email

tiuchi@chiba-cc.jp


Sponsor or person

Institute

Chiba Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Chiba Cancer Center

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Board, Chiba Cancer Center

Address

666 2 Nitonacho, Chuoku, Chiba, Japan

Tel

043-264-5431

Email

"k.mzn20@pref.chiba.lg.jp" <k.mzn20@pref.chiba.lg.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

千葉県がんセンター(千葉県)
Chiba Cancer Center (Chiba)


Other administrative information

Date of disclosure of the study information

2014 Year 11 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

Completed

Date of protocol fixation

2014 Year 05 Month 06 Day

Date of IRB

2014 Year 03 Month 25 Day

Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 30 Day

Last modified on

2020 Year 05 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018089


Research Plan
Registered date File name
2018/04/09 試験計画書v02.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name