NIPH Clinical Trials Search

UMIN ID: C000000183

Registered date:15/09/2005

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedPatients with stageII-IV Mullerian Carcinoma (Ovarian Epithelial,Primary Peritoneal,or Fallopian Tube Cancer)
Date of first enrollment2003/04/01
Target sample size600
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)combination of paclitaxel and carboplatin PTX180mg/m2, day1+CBDCA AUC6.0 day1 every 21 days for 6-9cycles combination of paclitaxel and carboplatin PTX80mg/m2 day1,8,15+CBDCA AUC6.0 day1 every 21 days for 6-9cycles


Primary OutcomeProgression-free Survival
Secondary OutcomeOverall Suvival/Adverse event/Clinical Objective Response/Quality of life

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
Include criteria
Exclude criteriaI. 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)

Related Information


public contact
Name Noriyuki Katsumata ,M.D.
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan
Telephone 03-3542-2511
Affiliation JGOG3016 Coordinating Office National Cancer Center Hospital
scientific contact
Name Makoto Yasuda ,M.D.
Address 3-19-18 Nishishinbashi,Minato-ku,Tokyo, 105-8461,Japan Japan
Telephone 03-3433-1111
Affiliation The Jikei University School of Medicine Department of Obsterics and Gynecology