UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014688
Receipt number R000017075
Scientific Title Temozolomide Challenge After Progressive disease
Date of disclosure of the study information 2014/07/29
Last modified on 2014/07/29 12:02:42

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Basic information

Public title

Temozolomide Challenge After Progressive disease

Acronym

TCAP study

Scientific Title

Temozolomide Challenge After Progressive disease

Scientific Title:Acronym

TCAP study

Region

Japan


Condition

Condition

malignant glioma

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy of temozoromide after progression disease in malignant glioma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)KPS, 2)survival time from PD, 3)adverse event

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1)Histologically confirmed malignant glioma
2)18 Years and older
3)Karnofsky performance status >/= 50%
4)no previous chemotherapy and radiotherapy
5)Patients who have undergone recent therapy recurrent or progressive tumor are eligible provided that a minimum of 28 days must have elapsed from the day of prior therapy
6)To have a proper organ function
7)Under the management responsibility of the study (sharing) doctor, contraception during the study is possible regardless of gender.
8)Laboratory values &#8203;&#8203;that were carried out before registration began meet one of the following criteria:.
Clinical test item standard
Neutrophil count (real) >/= 1,500 / mm3
Platelet count >/= 100,000 / mm3
Serum creatinine 1.5mg/dL or less

Key exclusion criteria

1)Patients with a history of hypersensitivity to dacarbazine or temozolomide.
2)Patients who are contraindicated to chemotherapeutic agents other than temozolomide.
3)The patient in need of surgery, additional radiotherapy to the PD after determination
4)Pregnant or lactating women
5)Double cancer of activity
6)It is complicated by pneumonia or meningitis in need of treatment.
7)Has been complicated by psychiatric symptoms or psychosis, it is determined that participation in the research is difficult.
8)patients have been complicated by uncontrolled diabetes.
9)patients have unstable angina or a history of myocardial infarction within 3 months.
10)And has a history of interstitial pneumonia or pulmonary fibrosis,.
11)When used interferon beta preparation maintenance therapy by temozolomide, patients corresponding to the following items are excluded.

Target sample size

39


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanori Ohnishi

Organization

Ehime University Graduated School of Medicine

Division name

neurosurgery

Zip code


Address

Shitsukawa, Toon city, Ehime, Japan

TEL

089-960-5338

Email

tohnishi@m.ehime-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shohei Kohono

Organization

Ehime University Graduated School of Medicine

Division name

neurosurgery

Zip code


Address

Shitsukawa, Toon city, Ehime, Japan

TEL

089-960-5338

Homepage URL


Email

kouno@m.ehime-u.ac.jp


Sponsor or person

Institute

Department of Neurosurgery Ehime University Graduated School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2014 Year 07 Month 29 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

No longer recruiting

Date of protocol fixation

2008 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 11 Month 01 Day

Last follow-up date

2015 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

It has been registered now ended, now Following.


Management information

Registered date

2014 Year 07 Month 28 Day

Last modified on

2014 Year 07 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017075


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name