UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016603
Receipt number 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 08:59:38

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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 Obstetrics 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 or person

Institute

Hyogo Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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