UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012400 |
|---|---|
| Receipt number | R000014501 |
| Scientific Title | Phase II Study of Paclitaxel in Combination with Carboplatin in Patients With Stage IB-II Cervical Cancer. |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2013/11/25 15:08:32 |
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Basic information
Public title
Phase II Study of Paclitaxel in Combination with Carboplatin in Patients With Stage IB-II Cervical Cancer.
Acronym
Phase II Study of TC in Patients With Cervical Cancer.
Scientific Title
Phase II Study of Paclitaxel in Combination with Carboplatin in Patients With Stage IB-II Cervical Cancer.
Scientific Title:Acronym
Phase II Study of TC in Patients With 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 of efficacy of TC in postoperative cervical cancer patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall 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
Pacritaxel 175mg/m2 and Carboplatin AUC 5 iv. triweekly, 6 cycles
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. The case that it was judged that additional adjuvant therapy was necessary after radical hysterectomy for cervical cancer.
2.PS <2
3.Nuet >1500/mm3
4.Plt >100000/mm3
Key exclusion criteria
1. within 6weeks after operation
2. active infection
3. the case witch doctor judged to be inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Ohmichi |
Organization
Osaka medical college
Division name
Obstetrics and Gynecology
Zip code
Address
2-7, Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
m-ohmichi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Kanemura |
Organization
Osaka medical college
Division name
Obstetrics and Gynecology
Zip code
Address
2-7, Daigaku-machi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
gyn044@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology,
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology,
Osaka Medical College
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
| 2013 | Year | 11 | Month | 25 | 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
| 2010 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 10 | 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
| 2013 | Year | 11 | Month | 25 | Day |
Last modified on
| 2013 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014501
