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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021727
Receipt No. 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

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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
Obsterics 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
Institute Kansai Clinical Oncology Group; KCOG
Institute
Department

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
URL(English) https://upload.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


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