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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028336
Receipt No. 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 2018/07/24

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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
Obsterics 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
Email 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
Email gyn092@osaka-med.ac.jp

Sponsor
Institute Obsterics and Gynecology in Osaka Medical College
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 25 Day
Last follow-up date
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
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032435

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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