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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Patients with stageII-IV Mullerian Carcinoma (Ovarian Epithelial,Primary Peritoneal,or Fallopian Tube Cancer)
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Classification by specialty |
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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 |
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Interventions/Control_1 | combination of paclitaxel and carboplatin
PTX180mg/m2, day1+CBDCA AUC6.0 day1 every 21 days for 6-9cycles |
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Interventions/Control_2 | combination of paclitaxel and carboplatin
PTX80mg/m2 day1,8,15+CBDCA AUC6.0 day1 every 21 days for 6-9cycles |
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Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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) |
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Target sample size | 600 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Japanese Gynecologic Oncology Group |
Institute | |
Department |
Funding Source | |
Organization | Japanese Gynecologic Oncology Group |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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.
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Recruitment status | Completed | ||||||
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Last modified on |
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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 |