UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000170 |
|---|---|
| Receipt number | R000000237 |
| Scientific Title | A phase II randomized study of DP(Docetaxel+Cisplatin),DJ(Docetaxel+Carboplatin),and TJ(Paclitaxel+Carboplatin) in patients with advanced and recurrent endometrial carcinoma |
| Date of disclosure of the study information | 2005/09/15 |
| Last modified on | 2010/12/20 11:35:55 |
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Basic information
Public title
A phase II randomized study of DP(Docetaxel+Cisplatin),DJ(Docetaxel+Carboplatin),and TJ(Paclitaxel+Carboplatin) in patients with advanced and recurrent endometrial carcinoma
Acronym
Evaluation of Taxane and Platinum combinations in patients with advanced and recurrent endometrial carcinoma
Scientific Title
A phase II randomized study of DP(Docetaxel+Cisplatin),DJ(Docetaxel+Carboplatin),and TJ(Paclitaxel+Carboplatin) in patients with advanced and recurrent endometrial carcinoma
Scientific Title:Acronym
Evaluation of Taxane and Platinum combinations in patients with advanced and recurrent endometrial carcinoma
Region
| Japan |
Condition
Condition
advanced or recurrent endometrial carcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to assess the efficacy and safety of the treatment with Taxane plus Platinum combination chemotherapy for advanced or recurrent endometrial carcinoma. The combinations of Taxane and Platinum are as follows; Docetaxel and Cisplatin, Docetaxel and Carboplatin, AND Paclitaxel and Carboplatin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Tumor Response
Key secondary outcomes
Toxicity, Feasibility, Progression free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel 70mg/m2+CDDP 60mg/m2 day1 q 3 weeks 3courses or more
Interventions/Control_2
Docetaxel 60mg/m2+CBDCA AUC 6 day1 q 3 weeks 3courses or more
Interventions/Control_3
Paclitaxel 180mg/m2+CBDCA AUC 6 day1 q 3 weeks 3courses or more
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
-Histologically confirmed endometrial carcinoma
-Stage III, IV, or recurrent disease
-Measurable disease
-At least 1 uni-dimensional measurable lesion >= 20 mm by conventional CT or MR OR >= 10 mm by helical CT scan
-At least 1 target lesion
-Prior therapy:
*At least 6 months since prior cytotoxic chemotherapy
*At least 4 weeks since prior radiotherapy
*At least 2 weeks since prior oral fluorouracil, hormonal or immunologic therapy
-Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
-Adequate bone marrow, hepatic, renal, cardiac and respiratory functions
-Written informed consent
Key exclusion criteria
-Patients with sarcomatous element
-Active infections
-Serious complications (heart disease, interstitial lung disease, uncontrolled hypertension, diabetes mellitus and tendency to bleeding)
-Massive pleural effusion or ascites
-Neuropathy grade 2 or more; edema grade 2 or more (NCI-CTC)
-Active concomitant malignancy
-Hypersensitivity to Polysorbate 80 or Cremophor EL
-Patients judged inappropriate for this study by the physicians
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Aoki, M.D. |
Organization
School of Medicine, Keio University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Aoki, M.D. |
Organization
JGOG2041 Coordinating Office
Division name
Department of Obstetrics and Gynecology, School of Medicine, Keio University
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL
03-3353-1211
Homepage URL
http://www.jgog.gr.jp/
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japanese Gynecologic Oncology Group
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
| 2005 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://annonc.oxfordjournals.org/content/early/2010/08/07/annonc.mdq401.abstract?sid=ae1bc117-d083-4f07-a1f4-a72f54030cf8
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
Completed
Date of protocol fixation
| 2003 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2010 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000237
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