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
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/
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
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
