UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021727
Receipt number R000025061
Scientific Title Neoadjuvant irinotecan and nedaplatin followed by radical hysterectomy for bulky stage Ib/II cervical cancer
Date of disclosure of the study information 2016/04/07
Last modified on 2016/04/01 00:58:36

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Basic information

Public title

Neoadjuvant irinotecan and nedaplatin followed by radical hysterectomy for bulky stage Ib/II cervical cancer

Acronym

KCOG-G1201 study

Scientific Title

Neoadjuvant irinotecan and nedaplatin followed by radical hysterectomy for bulky stage Ib/II cervical cancer

Scientific Title:Acronym

KCOG-G1201 study

Region

Japan


Condition

Condition

stage IB2-IIb of uterine cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of neoadjuvant irinotecan and nedaplatin followed by radical hysterectomy for bulky staged IB2-IIB cervical cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

2 year overall survival rate

Key secondary outcomes

reponse rate of the neoadjuvant chemotherapy, adverse events rate


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

neoadjuvant 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

75 years-old >=

Gender

Female

Key inclusion criteria

1) pathologically diagnosed with squamous cell carcinoma in uterine of the cervix
2) stageIB2-IIb with bulky tumor (more than 4cm)
3) no previous therapy
4) ECOG performance status 0-1
5) Neutrocyte > 2,000/mm3
Platelet > 100,000/mm2
Hemoglobin > 9.0 g/dL
AST, ALT < 100IU/L
Total bilirubin < 1.5mg/dL
Serum creatinine < 1.5mg/dL
Creatinine clearance >60ml/min
6) obtained informed consent

Key exclusion criteria

1) remarkable infection
2) severe complications (heart disease, incontorable diabetes)
3) with other malignancies
4) interstitial pneumonia
5) massive ascites
6) severe diarrhea
7) ileus
8) pregnant women
9) past history of severe allergy for drug

Target sample size

68


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taisuke Mori

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code


Address

465 Kajii-cho, Kamigyo-ku, Kyoto city , Kyoto, Japan

TEL

075-251-5560

Email

moriman@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taisuke Mori

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Obstetrics and Gynecology

Zip code


Address

465 Kajii-cho, Kamigyo-ku, Kyoto city , Kyoto, Japan

TEL

075-251-5560

Homepage URL

http://www.kcog.net/

Email

moriman@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kansai Clinical Oncology Group; KCOG

Institute

Department

Personal name



Funding Source

Organization

Kansai Clinical Oncology Group; KCOG

Organization

Division

Category of Funding Organization

Non profit foundation

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

岐阜大学病院(岐阜県)、関西ろうさい病院(兵庫県)、京都府立医科大学(京都府)、千船病院(大阪府)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 07 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

Date of protocol fixation

2012 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 29 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

2016 Year 04 Month 01 Day

Last modified on

2016 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025061


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name