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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017232
Receipt No. R000014862
Scientific Title A phase II study of concurrent weekly carboplatin and paclitaxel combined with definitive radiotherapy for advanced-stage cervical cancer.
Date of disclosure of the study information 2015/04/22
Last modified on 2018/11/22

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Basic information
Public title A phase II study of concurrent weekly carboplatin and paclitaxel combined with definitive radiotherapy for advanced-stage cervical cancer.
Acronym A phase II study of concurrent weekly carboplatin and paclitaxel combined with definitive radiotherapy for advanced-stage cervical cancer.
Scientific Title A phase II study of concurrent weekly carboplatin and paclitaxel combined with definitive radiotherapy for advanced-stage cervical cancer.
Scientific Title:Acronym A phase II study of concurrent weekly carboplatin and paclitaxel combined with definitive radiotherapy for advanced-stage cervical cancer.
Region
Japan

Condition
Condition Uterine cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of weekly carboplatin plus paclitaxel combined with definitive radiotherapy for patients with advanced-stage cervical cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Concurrent weekly carboplatin and paclitaxel combined with pelvic radiotherapy
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 FIGO stage IIIb or IVa cervical cancer
Key exclusion criteria FIGO stage Ia-IIIa cervical cancer
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Kimura
Organization Osaka University Hospital
Division name Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3351
Email tadashi@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Mabuchi
Organization Osaka University Hospital
Division name Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3351
Homepage URL
Email smabuchi@gyne.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

Funding Source
Organization None
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
2015 Year 04 Month 22 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
2012 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 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
2015 Year 04 Month 22 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014862

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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