UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009459 |
|---|---|
| Receipt number | R000010897 |
| Scientific Title | Phase II/II study of Adriamycin and Cisplatin versus Adriamycin for TC or DC resistant endometrial cancer |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2012/12/02 18:52:28 |
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Basic information
Public title
Phase II/II study of Adriamycin and Cisplatin versus Adriamycin for TC or DC resistant endometrial cancer
Acronym
Phase II/II study of Adriamycin and Cisplatin versus Adriamycin for TC or DC resistant endometrial cancer
Scientific Title
Phase II/II study of Adriamycin and Cisplatin versus Adriamycin for TC or DC resistant endometrial cancer
Scientific Title:Acronym
Phase II/II study of Adriamycin and Cisplatin versus Adriamycin for TC or DC resistant endometrial cancer
Region
| Japan |
Condition
Condition
recurrent endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and toxicity of adriamycin and cisplatin or adriamycin for TC(paclitaxel, carboplatin) or DC(docetaxel, carboplatin) resistant endometrial cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
overall survival, response rate, toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AP therapy (Adriamycin 60mg/m2, cisplatin 50mg/m2 day1 q 3weeks) 20cases, registration period is from 01/01/2013 - 12/31/2015, follow up period is until 12/31/-2018
Interventions/Control_2
A therapy (Adriamycin 60mg/m2 day1 q 3weeks) 20cases, registration period is from 01/01/2013 - 12/31/2015, follow up period is until 12/31/-2018
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
paclitaxel/carboplatin or docetaxel/carboplatin resistant recurrent endometrial cancer
having lesion measured by CT or MRI
ECOG PS 0 or 1
Key exclusion criteria
Obvious infection, serous complication (heart disease, intestinal pneumonia, bleeding)
edema greater than grade 2
neuropathy greater that\n grade 2
active other cancer
symptomatic brain metastasis
pleural effusion or ascites needed treatment
pericardiac effusion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Irahara |
Organization
Tokushima University hospital
Division name
Obstetrics and Gynecology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Nishimura |
Organization
Tokushima University hospital
Division name
Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
nisimura@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University hospital
Institute
Department
Personal name
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
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 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 02 | Day |
Last modified on
| 2012 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010897
