UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019225 |
|---|---|
| Receipt number | R000022218 |
| Scientific Title | A phase II study combining gemcitabine and carboplatin in patients with platinum-resistant ovarian cancer |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2020/01/24 21:09:39 |
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Basic information
Public title
A phase II study combining gemcitabine and carboplatin in patients with platinum-resistant ovarian cancer
Acronym
A phase II study combining gemcitabine and carboplatin in patients with platinum-resistant ovarian cancer
Scientific Title
A phase II study combining gemcitabine and carboplatin in patients with platinum-resistant ovarian cancer
Scientific Title:Acronym
A phase II study combining gemcitabine and carboplatin in patients with platinum-resistant ovarian cancer
Region
| Japan |
Condition
Condition
patients with platinum-resistant ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the feasibility and effect of combination of gemcitabine and carboplatin in patients with platinum-resistant ovarian cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical responce
Key secondary outcomes
side effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We choice the combination of gemcitabine and carboplatin as the regimen of chemotherapy in platinum-resistant ovarian cancer.
We throw the chemotherapy once per 3 weeks.
Day1: gemcitabine 800mg/m2+Carboplatin AUC=4
Day8: gemcitabine 800mg/m2
We estimate the effect using CT once at 3 cycles.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
patients in platinum-resistant ovarian cancer who were given the combination of paclitaxel and carboplatin as prior chemotherapy
Key exclusion criteria
The organization type including sarcoma
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Ohmichi |
Organization
The Osaka medical coledge
Division name
Gynecologic oncology
Zip code
Address
2-7 Daigakucho Tatsuki Osaka
TEL
072-683-1221
m-ohmichi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoe Fujiwara |
Organization
The Osaka medical coledge
Division name
Gynecologic oncology
Zip code
Address
2-7 Daigakucho Tatsuki Osaka
TEL
972-683-1221
Homepage URL
gyn092@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical coledge
Institute
Department
Personal name
Funding Source
Organization
Osaka medical coledge
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
| 2015 | Year | 10 | Month | 05 | 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
| 2015 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2015 | Year | 10 | Month | 03 | 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=R000022218
