UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017808 |
|---|---|
| Receipt number | R000020631 |
| Scientific Title | Phase II study of radical hysterecotmy and perioperative chemotherpy with Docetaxel and Carboplatin for cervical cancer |
| Date of disclosure of the study information | 2015/06/05 |
| Last modified on | 2015/06/04 11:20:44 |
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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
| Obstetrics 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
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
akirak@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical university International Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020631
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
