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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000170
Receipt No. 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

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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
Obsterics 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
Email

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/
Email

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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