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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000183
Receipt No. R000000254
Scientific Title Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma (Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer)
Date of disclosure of the study information 2005/09/15
Last modified on 2009/09/30

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Basic information
Public title Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma (Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer)
Acronym Randomized Trial of tri-weekly TJ vs. weekly TJ for Stage II-IV Mullerian Carcinoma
Scientific Title Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma (Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer)
Scientific Title:Acronym Randomized Trial of tri-weekly TJ vs. weekly TJ for Stage II-IV Mullerian Carcinoma
Region
Japan

Condition
Condition Patients with stageII-IV Mullerian Carcinoma (Ovarian Epithelial,Primary Peritoneal,or Fallopian Tube Cancer)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Progression-free Survival
Key secondary outcomes Overall Suvival/Adverse event/Clinical Objective Response/Quality of life

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 considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 combination of paclitaxel and carboplatin
PTX180mg/m2, day1+CBDCA AUC6.0 day1 every 21 days for 6-9cycles
Interventions/Control_2 combination of paclitaxel and carboplatin
PTX80mg/m2 day1,8,15+CBDCA AUC6.0 day1 every 21 days for 6-9cycles
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria I. Histologically confirmed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer
II. No prior chemotherapy
III. Age: 20 and more
IV. Performance status: ECOG 0-2
V. 1) Absolute neutrophil count at least 1,500/mm3
2) Platelet count at least 100,000/mm3
3) Bilirubin less than 1.5mg/dL
4) SGOT less than 100 IU/l
5) Serum creatinine less than 1.5mg/dL
VI. Written informed consent
Key exclusion criteria I. Patients with ovarian borderline tumor
II. Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer those are curable with local therapy
III. Patients with active infection or uncontrolled diabetes
IV. Patients with unstable angina, or those who have had a myocardial infarction within the past 6 months, or patients with serious arrythmia that requires medication
V. Patients who have a history of hypersensitivity to polyoxyethylated castor oil (Cremophor EL)
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Yasuda ,M.D.
Organization The Jikei University School of Medicine
Division name Department of Obsterics and Gynecology
Zip code
Address 3-19-18 Nishishinbashi,Minato-ku,Tokyo, 105-8461,Japan
TEL 03-3433-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Katsumata ,M.D.
Organization JGOG3016 Coordinating Office
Division name National Cancer Center Hospital
Zip code
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Homepage URL http://www.jgog.gr.jp/
Email nkatsuma@ncc.go.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization Non profit foundation
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 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.thelancet.com/journals/lancet/onlinefirst
Number of participants that the trial has enrolled
Results
631 of the 637 enrolled patients were eligible for treatment and were included in the ITT population (dose-dense regimen, n=312; conventional regimen, n=319). Median progression-free survival was longer in the dose-dense treatment group (28-0 months, 95% CI 22.3-35.4) than in the conventional treatment group (17.2 months, 15.7-21.1hazard ratio [HR] 0&#8226;71; 95% CI 0&#8226;58&#8212;0&#8226;88; p=0&#8226;0015). Overall survival at 3 years was higher in the dose-dense regimen group (72&#8226;1%) than in the conventional treatment group (65&#8226;1%; HR 0&#8226;75, 0&#8226;57&#8212;0&#8226;98; p=0&#8226;03). 165 patients assigned to the dose-dense regimen and 117 assigned to the conventional regimen discontinued treatment early. Reasons for participant dropout were balanced between the groups, apart from withdrawal because of toxicity, which was higher in the dose-dense regimen group than in the conventional regimen group (n=113 vs n=69). The most common adverse event was neutropenia (dose-dense regimen, 286 [92%] of 312; conventional regimen, 276 [88%] of 314). The frequency of grade 3 and 4 anaemia was higher in the dose-dense treatment group (214 [69%]) than in the conventional treatment group (137 [44%]; p<0&#8226;0001). The frequencies of other toxic effects were similar between groups.

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 04 Month 16 Day
Date of IRB
Anticipated trial start date
2003 Year 04 Month 01 Day
Last follow-up date
2007 Year 09 Month 01 Day
Date of closure to data entry
2007 Year 10 Month 01 Day
Date trial data considered complete
2007 Year 11 Month 01 Day
Date analysis concluded
2008 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2009 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000254

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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