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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000155
Receipt No. 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

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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
Obsterics 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
Email

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
Email hosokawa@koto.kpu-m.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000223

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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