UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003476 |
|---|---|
| Receipt number | R000004200 |
| Scientific Title | Phase II study of Weekly Paclitaxel+Weekly Carboplatin for Platinum/Taxan sensitive recurrent mullerian carcinoma |
| Date of disclosure of the study information | 2010/04/12 |
| Last modified on | 2010/04/11 23:23:20 |
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Basic information
Public title
Phase II study of Weekly Paclitaxel+Weekly Carboplatin for Platinum/Taxan sensitive recurrent mullerian carcinoma
Acronym
Phase II study of Platinum/Taxan sensitive recurrent mullerian carcinoma
Scientific Title
Phase II study of Weekly Paclitaxel+Weekly Carboplatin for Platinum/Taxan sensitive recurrent mullerian carcinoma
Scientific Title:Acronym
Phase II study of Platinum/Taxan sensitive recurrent mullerian carcinoma
Region
| Japan |
Condition
Condition
Platinum/Taxan sensitive recurrent mullerian carcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the combination regimen with Weekly Paclitaxel+Weekly Carboplatin for Platinum/Taxan sensitive recurrent mullerian carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
(1)Overall survival
(2)Progression free survival
(3)Incidence of morbidity
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 |
Interventions/Control_1
Paclitaxel 80mg/m2 day1,8,15+Carboplatin AUC=2 day1,8,15
q 4weeks 6cycle
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.Histology or cytologically confirmed ovarian epithelial,primary peritoneal cabity,or fallopian tube cancer.
2.Failed prior primary pratinum-based therapy.(Progression-free interval>=6months)
3.Measurable lesion by CTscan,MRI
4.Age 20-75
5.ECOG performance status(PS)0-2
6.Patient characteristics
Inclusion criteria:
6-1.ANC1,500/mm3
6-2.Platelet count>=100,000/mm3
6-3.ALT and AST=<2.5xULN
6-4.Serum bilirubin=<1.5mg/dL
6-5.Creatinine=<1.5mg/dL
7.Patient provided written informed concent befor initiation of study-related procedures.
Key exclusion criteria
1.Progression free interval<6months
2.Prior chemotherapy>2regimen
3.Pleural effusion need to continued drainage.
4.Evidense of severe or uncontrolled cardiac disease.
5.Hystory of myocardial infarction within 6months.
6.Hystory of cirrhosis or active hepatitis.
7.Severe plumonary disease(interstitial pneumonia,pulmonary fibrosis,)8.Gastrointestinal bleeding that requires iteration transfusion.
9.Serius psychological disease.
10.Uncontrolled diabetes.
11.Bowel obstruction.
12.Infection with fever.
13.Active double carcinoma.
14.Symptomatic brain metastasis.
15.Accute inflammatory desease.
16.Sevre peripheral neuropathy.
17.Patients with any history of serious drug reactions
18.History of hyper sensitivity to polyoxyethylene castor oil(ChremophorEL) or contained castor oil(vitamin injection)
19.Pregnant or lactating woman.
20.Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Yasuda |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3256 Midorimachi,Tachikawa-city,Tokyo,190-0014 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyosuke Yamada |
Organization
Jikei University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3-19-18 Nishishinbashi,Minato-ku,Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Japan Kanto Tumor Board(JKTB)
Institute
Department
Personal name
Funding Source
Organization
Japan Kanto Tumor Board(JKTB)
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
| 2010 | Year | 04 | Month | 12 | 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
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | 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
| 2010 | Year | 04 | Month | 11 | Day |
Last modified on
| 2010 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004200
