UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Concurrent chemoradiotherapy with paclitaxel and carboplatin for stage III or IVA cervical cancer with renal dysfunction
Title of the study (Brief title)	CCRT with TC for cervical cancer
Region	Japan

Condition
Condition	Locally advanced stage III or IVA cervical cancer with renal dysfunction
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of CCRT with TC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cancellation rate by adverse events
Key secondary outcomes

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	Radiotherapy and chemotherapy
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	Patients diagnosed stage III or IVA cervical cancer with renal dysfunction (eGFR is less than 60)
Key exclusion criteria	Patients treated with paclitaxel or carboplatin previously
Target sample size	32

Research contact person
Name of lead principal investigator	Yuichi Imai
Organization	Yokohama City University Hospital
Division name	Department of Obstetrics and gynecology
Address	3-9 Fukuura, Kanazawa, Yokohama, Kanagawa 236-0004, Japan
TEL	045-787-2800
Email	you11sep@gmail.com

Public contact
Name of contact person	Yuichi Imai
Organization	Yokohama City University Hospital
Division name	Department of Obstetrics and gynecology
Address	3-9 Fukuura, Kanazawa, Yokohama, Kanagawa 236-0004, Japan
TEL	045-787-2800
Homepage URL
Email	you11sep@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
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	2017 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 04 Month 01 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	2017 Year 02 Month 07 Day
Last modified on	2017 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029920