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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014688
Receipt No. R000017075
Scientific Title Temozolomide Challenge After Progressive disease
Date of disclosure of the study information 2014/07/29
Last modified on 2014/07/29

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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
Last 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
1st 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
Institute Department of Neurosurgery Ehime University Graduated School of Medicine
Institute
Department

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
URL(English) https://upload.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


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