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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000564
Receipt No. R000000685
Scientific Title Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
Date of disclosure of the study information 2007/01/01
Last modified on 2015/09/30

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Basic information
Public title Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
Acronym Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
Scientific Title Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
Scientific Title:Acronym Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent 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 combination chemotherapy consisting of docetaxel and carboplatin in patients with stage IVb recurrent 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, Overall survival

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 IVb recurrent 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 1.Patients having measurable lesions with definite histopathological diagnosis of stage IVb or recurrent nonsquamous cell carcinoma of uterine cervix
2.Recurrent patients can received any prior treatment including chemotherapy or radiotherapy as far as having interval more than 4 weeks. Concurrent combination radiotherapy can not be permitted.
3.Performance status: 0-2
4.Age: 20-75 years old
5.Patients without severe dysfunction of major organs
6.Patients can be alive over 3 moths after treatment
7.Patients must have signed 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.Massive pleural effusion and ascites
8.Hypersensitivity reactions to docetaxel or carboplatin
9.Patients judged as exclusive case by the investigator
Target sample size 50

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, Shimame
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
Institute
Department

Funding Source
Organization Sankai Gynecology Study Group
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
2007 Year 01 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 Completed
Date of protocol fixation
2006 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 12 Month 27 Day
Last modified on
2015 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000685

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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