UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028336 |
|---|---|
| Receipt number | R000032435 |
| Scientific Title | The prospective study of weekly Paclitaxel and Carboplatin for elderly patients with gynecologic cancer |
| Date of disclosure of the study information | 2017/07/25 |
| Last modified on | 2020/01/24 21:08:38 |
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Basic information
Public title
The prospective study of weekly Paclitaxel and Carboplatin for elderly patients with gynecologic cancer
Acronym
Weekly TC for elderly patients
Scientific Title
The prospective study of weekly Paclitaxel and Carboplatin for elderly patients with gynecologic cancer
Scientific Title:Acronym
Weekly TC for elderly patients
Region
| Japan |
Condition
Condition
Patients older than 75 years old with gynecologic cancer who are administered Paclitaxel and Carboplatin
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and torelable of weekly Paclitaxel and Carboplatin in elderly patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The degree of accomplishment in 6 courses
Key secondary outcomes
Profression free survival in 2 years
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who are older than 75 years with gynecologic cancers
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
Older than 75 years old
Diagnosed Gynecologic cancer
Adaptation for chemotherapy of TC rejimen
Key exclusion criteria
Performance status is under 3
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoe Fujiwara |
Organization
Osaka Medical College
Division name
Obsterics and Gunecology
Zip code
Address
Daigakumati 2-7, Takatuki, Osaka
TEL
072-683-1221
gyn092@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoe Fujiwara |
Organization
Osaka Medical College
Division name
Obsterics and Gunecology
Zip code
Address
Daigakumati 2-7, Takatuki, Osaka
TEL
072-683-1221
Homepage URL
gyn092@osaka-med.ac.jp
Sponsor or person
Institute
Obsterics and Gynecology in Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Obsterics and Gynecology in Osaka Medical College
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
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
| 2017 | Year | 07 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032435
| 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 |
