UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026034
Receipt number R000029920
Scientific Title Concurrent chemoradiotherapy with paclitaxel and carboplatin for stage III or IVA cervical cancer with renal dysfunction
Date of disclosure of the study information 2017/04/01
Last modified on 2017/02/07 18:33:21

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Basic information

Public title

Concurrent chemoradiotherapy with paclitaxel and carboplatin for stage III or IVA cervical cancer with renal dysfunction

Acronym

CCRT with TC for cervical cancer

Scientific Title

Concurrent chemoradiotherapy with paclitaxel and carboplatin for stage III or IVA cervical cancer with renal dysfunction

Scientific Title:Acronym

CCRT with TC for cervical cancer

Region

Japan


Condition

Condition

Locally advanced stage III or IVA cervical cancer with renal dysfunction

Classification by specialty

Obstetrics 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

1st name
Middle name
Last name Yuichi Imai

Organization

Yokohama City University Hospital

Division name

Department of Obstetrics and gynecology

Zip code


Address

3-9 Fukuura, Kanazawa, Yokohama, Kanagawa 236-0004, Japan

TEL

045-787-2800

Email

you11sep@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yuichi Imai

Organization

Yokohama City University Hospital

Division name

Department of Obstetrics and gynecology

Zip code


Address

3-9 Fukuura, Kanazawa, Yokohama, Kanagawa 236-0004, Japan

TEL

045-787-2800

Homepage URL


Email

you11sep@gmail.com


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



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)



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

2017 Year 04 Month 01 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

Preinitiation

Date of protocol fixation

2017 Year 01 Month 20 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029920


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name