UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000183 |
|---|---|
| Receipt number | 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 11:40:15 |
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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
| Obstetrics 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
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/
nkatsuma@ncc.go.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
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
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•71; 95% CI 0•58—0•88; p=0•0015). Overall survival at 3 years was higher in the dose-dense regimen group (72•1%) than in the conventional treatment group (65•1%; HR 0•75, 0•57—0•98; p=0•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•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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000254
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