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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000560
Receipt No. R000000682
Scientific Title Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Date of disclosure of the study information 2007/01/01
Last modified on 2014/05/02

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Basic information
Public title Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Acronym Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Scientific Title Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Scientific Title:Acronym Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Region
Japan

Condition
Condition nonsquamous cell carcinoma of uterine cervix
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety for neoadjuvant chemotherapy consisting of docetacel and carboplatin in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Efficacy
Key secondary outcomes Safety

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 patients with stage Ib2 or II with diameter of over 2 cm nonsquamous cell carcinoma of uterine cervix
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 The eligibility requirements for entry into this study included a histologically confirmed diagnosis of nonsquamlous cell carcinoma of uterine cervix and no prior chemotherapytreatment. All patients were required to have a Eastern Cooperative Oncology Group performance status of <3, age 20 to 75 years, and adequate bone marrow function, liver function, and renal function defined by neutrophils > 2,000/mm3, platelets > 100,000/mm3, serum AST and ALT < 100 IU/l, serum ALP < 750 IU/l, serum total bilirubin < 1.5 mg/dl, and serum creatinine < 1.5 mg/dl. All patients were required to provide written informed consent.
Key exclusion criteria 1 fever with over 38.0C
2 infection or WBC>12,000/mm3
3 severe complications
4 neuropathy >Grade 2
5 edema > Grade 2
6 double cancer
7 pleural effusion and ascites for which drainage are necessary.
8 previous chemotherapy by taxane compounds
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junzo Kigawa
Organization Matsue city hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 32-1 Noshiro-cho, Matsue, Shimane
TEL 0852-60-8000
Email mshima12@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Muneaki Shimada
Organization Tottori University
Division name Department of Obstetrics and Gynecology
Zip code
Address 36-1 Nishimachi, Yonago Japan
TEL 0859-38-6647
Homepage URL
Email mshima12@med.tottori-u.ac.jp

Sponsor
Institute Sankai Gynecology Study Group (SGSG)
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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
2007 Year 01 Month 01 Day

Related information
URL releasing protocol http://www.sgsg.biz/
Publication of results Published

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 Completed
Date of protocol fixation
2006 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 12 Month 26 Day
Last modified on
2014 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000682

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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