UMIN-CTR Clinical Trial

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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