UMIN-CTR Clinical Trial

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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