UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety of 4-step carboplatin desensitization for patients with gynecological malignancies showing platinum hypersensitivity, a prospective multi-center study
Title of the study (Brief title)	Safety of 4-step carboplatin desentization
Region	Japan

Condition
Condition	uterine cervical cancer, uterine corpus cancer, ovarian cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of the 4-step method carboplatin desensitization for patients showing platinum hypersensitivity reactions , compared with the 12-step method
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Relapse rate of hypersensitivity reaction
Key secondary outcomes	Search for risk factors for relapse of hypersensitivity reaction

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	carboplatin desensitization
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	75 years-old >=
Gender	Female
Key inclusion criteria	. recurrent of ovarian cancer or uterine corpus cancer or uterine cervical cancer . PS 0-1 . hypersensitivity reactions (<CTCAE Grade 3)of carboplatin at previous therapy . platinum free interval > 6 months . regard to informed consent of this research
Key exclusion criteria	. with active infection . with serious complications (such as poorly controlled high blood pressure and diabetes, bleeding tendency, collagen disease requiring steroid administration) . with active double cancer . complicated of serum sickness, Stevens-Johnson syndrome, toxic epidermal necrosis . judged unsuitable by doctor
Target sample size	45

Research contact person
Name of lead principal investigator	MATSUNAGA TATSUYA
Organization	Yokohama city university
Division name	Obstetrics & Gynecology
Address	3-9 in Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa
TEL	045-787-2800
Email	tyamatsu@yokohama-cu.ac.jp

Public contact
Name of contact person	MATSUNAGA TATSUYA
Organization	Yokohama city university
Division name	Obstetrics & Gynecology
Address	3-9 in Fukuura, Kanazawa-ku, Yokohama-shi, Kanagawa
TEL	045-787-2800
Homepage URL
Email	tyamatsu@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university Obstetrics & Gynecology
Institute
Department

Funding Source
Organization	Yokohama city university Obstetrics & Gynecology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 05 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 14 Day
Last modified on	2018 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036772