UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer
Acronym	Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer
Scientific Title	Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer
Scientific Title:Acronym	Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	disease 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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin
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.Cervical cancer patients stage IB2, IIA2, IIB, and III 2. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 3. Main medical conditions must be well-controlled 4. Have a life expectancy of at least 3 months, as estimated by the investigator 5. Subject must provide written informed consent and be wiling and able to comply with all aspects of the protocol 6. Laboratory results within the 1 week prior to Registration must be as follows: -Absolute neutrophil count > 1,500 cells/mm3 -Bilirubin < 1.5 mg/dL -Creatinine < 1.5 mg/dL -Asparatate Aminotransferse (AST) and Alanine Aminotransferase (ALT) < 100 U/L -Platelet count > 100,000 cells/mm3 7. Must evaluate MRI and CT scan within 1 month prior to registration
Key exclusion criteria	1. Having fever more than 38.0 degrees 2. Active serious systemic disease, including active bacterial or fungal infection. 3. Clinically siginificant heart disease or other complications. 4. Evidence of other active invasive malignancy. 5. Previous treatment with Taxens and/or Platinums. 6. Any medical or other condition that, in the opinion of the investigator, would preclude the subjects' participation in a clinical study including medical contraindications.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Kurosaki
Organization	Saitama Medical university International Medical Center
Division name	Gynecogic Oncology
Zip code
Address	1397-1 Yamane, Hidaka-city, Saitama, Japan
TEL	+81-42-984-4111
Email	akirak@saitama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akira Kurosaki
Organization	Saitama Medical university International Medical Center
Division name	Gynecogic Oncology
Zip code
Address	1397-1 Yamane, Hidaka-city, Saitama, Japan
TEL	+81-42-984-4111
Homepage URL
Email	akirak@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical university International Medical Center
Institute
Department

Funding Source
Organization	Saitama Medical university International Medical Center
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 06 Month 05 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	Open public recruiting
Date of protocol fixation	2013 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date	2013 Year 07 Month 03 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 06 Month 04 Day
Last modified on	2015 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020631

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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