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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016603
Receipt No. R000018276
Scientific Title A feasibility study of carboplatin desensitization protocol in ovarian cancer
Date of disclosure of the study information 2015/02/23
Last modified on 2016/02/24

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Basic information
Public title A feasibility study of carboplatin desensitization protocol in ovarian cancer
Acronym A feasibility study of carboplatin desensitization protocol in ovarian cancer
Scientific Title A feasibility study of carboplatin desensitization protocol in ovarian cancer
Scientific Title:Acronym A feasibility study of carboplatin desensitization protocol in ovarian cancer
Region
Japan

Condition
Condition ovarian cancer
Classification by specialty
Hematology and clinical oncology Clinical immunology Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We prospectively examine the efficacy and safety of desensitization protocol with ovarian cancer patients who have experienced hypersensitive reaction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Completion rate of desensitization protocol
Key secondary outcomes Efficacy
Progression free survival
Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carboplatin
desensitization
every 3 or 4 weeks
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

Not applicable
Gender Female
Key inclusion criteria 1)Patients need a histologically or cytologically diagnosis of ovarian malignancy(including peritoneal cancer and fallopian tube cancer).
2)Platinum-free interval > 6 monthes.
3)They are 20 years or older.
4)They have Eastern Cooperative Oncology Group(ECOG)performance status of 0-2.
5)They have experienced hypersensitive reaction with carboplatin.
6)They have adequate organ functions.
7)Written informed consent by the patient.
Key exclusion criteria 1)Continuous medication with antihistamine.
2)Active systemic infections to be treated.
3)Active multiple primart cancer (prognosis < 12 monthes)
4)With severe complications.
5)Women during pregnancy, possible pregnancy, or breast-feeding.
6)Psychiatric disease.
7)Continuous systemic steroid treatment.
8)doctor's decision not to be registered to this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Matsumoto
Organization Hyogo Cancer Center
Division name Division of Medical Oncology
Zip code
Address 13-70, Kita-oji, Akashi, Hyogo, Japan
TEL 078-929-1151
Email kojmatsu@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Matsumoto
Organization Hyogo Cancer Center
Division name Division of Medical Oncology
Zip code
Address 13-70, Kita-oji, Akashi, Hyogo, Japan
TEL 078-929-1151
Homepage URL
Email kojmatsu@hp.pref.hyogo.jp

Sponsor
Institute Hyogo Cancer Center
Institute
Department

Funding Source
Organization Hyogo Cancer Center
Organization
Division
Category of Funding Organization Local Government
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 兵庫県立がんセンター(兵庫県)
日本医大武蔵小杉病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 23 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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 23 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 22 Day
Last modified on
2016 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018276

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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