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 ​​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
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
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
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
