UMIN-CTR Clinical Trial

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

Sponsor
Institute	Osaka medical coledge
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022218