UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015649 |
|---|---|
| Receipt number | R000018193 |
| Scientific Title | Observational study of chemotherapy in thymic cancer patients. |
| Date of disclosure of the study information | 2014/11/11 |
| Last modified on | 2020/05/15 13:58:44 |
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Basic information
Public title
Observational study of chemotherapy in thymic cancer patients.
Acronym
NEJ023
Scientific Title
Observational study of chemotherapy in thymic cancer patients.
Scientific Title:Acronym
NEJ023
Region
| Japan |
Condition
Condition
Thymic cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate chemotherapeutic regimens and their efficacy in patietns with thymic cancer. And, to investigate a correlation between efficacy of chemotherapy and patient's characteristics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival (OS)
Key secondary outcomes
OS from the initiation of 2nd line chemotherapy, OS from the initiation of 3rd line chemotherapy, treatment duration, response rate, progression free survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with histologically confirmed thymic cancer.
2.Patients who were difficult to treat with radical surgery or radical radiation therapy at diagnosis.
3.Patients who were received 1st line chemotherapy between 01/04/1995 and 31/03/2014.
Key exclusion criteria
Not applicable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Department of Respiratory Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1062
kztakaha@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ryo Ko |
| Middle name | |
| Last name | Takehito Shukuya |
Organization
Juntendo University
Division name
Department of Respiratory Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5802-1062
Homepage URL
rkou@juntendo.ac.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
IRB of Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1589
hmasuko@juntendo.ac.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
324
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
| 2014 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate chemotherapeutic regimens and their efficacy in patietns with thymic cancer. And, to investigate a correlation between efficacy of chemotherapy and patient's characteristics.
Management information
Registered date
| 2014 | Year | 11 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018193
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
