UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000155 |
|---|---|
| Receipt number | R000000223 |
| Scientific Title | randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA |
| Date of disclosure of the study information | 2005/10/01 |
| Last modified on | 2017/06/12 11:36:57 |
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Basic information
Public title
randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA
Acronym
randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA
Scientific Title
randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA
Scientific Title:Acronym
randomized phase 2 study of Docetaxel+CBDCA versus weekly Paclitaxel+CBDCA
Region
| Japan |
Condition
Condition
ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The combination of paclitaxel and carboplatin every 3 weeks is considered as a standard first line chemotherapy for the of patients with advanced ovarian cancer. However,this treatment often produced severe neurotoxicity. A randomized trial demonstrated that the combination of docetaxel and carboplatin had a similiar efficacy to paclitaxel and carboplatin. The treatment had less neurotoxicity,but greater myelosuppression compared with paclitaxel-carboplatin. On the other hand, and weekly paclitaxel as substitute for 3 weeks and carboplatin was reported to have similiar response and less neurotoxicity. Our aim is to examine efficacy ety of docetaxel-carboplatin versus weekly paclitaxel and carboplatin for advanced ovarian cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
quality of life ,safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
docetaxel and carboplatin
Interventions/Control_2
weekly paclitaxel and carboplatin
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with histologically or cytologically confirmed epitheral ovarian cancer, fallopian tubal cancer or peritoneal cancer. performance status(ECOG)0-2. no prior chemotherapy. adequate levels of bone marrow,hepatic,and renal function. n. no heart failure and pulmonary disease. no active infection. no
other malignancies. signing of an informed consent document.
Key exclusion criteria
pregnant or nursing woman
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yamaguchi |
Organization
osaka medical college
Division name
department of obstetrics and gynecology
Zip code
Address
Daigakucho2-7 Takatuki city Osaka Japan
TEL
0726-83-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Hosokawa |
Organization
Kyoto Prefectual University
Division name
department of obstetrics and gynecology
Zip code
Address
Kajiicho465 Kamigyoku Kyoto city Japan
TEL
075-251-5560
Homepage URL
hosokawa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Kansai Clinical Oncology Group
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
| 2005 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2001 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000223
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
