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)

UMIN ID: C000000183

Registered date:15/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with stageII-IV Mullerian Carcinoma (Ovarian Epithelial,Primary Peritoneal,or Fallopian Tube Cancer)
• Date of first enrollment: 2003/04/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

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

Outcome(s)

• Primary Outcome: Progression-free Survival
• Secondary Outcome: Overall Suvival/Adverse event/Clinical Objective Response/Quality of life

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude 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)

Related Information

• Primary Sponsor: Japanese Gynecologic Oncology Group
• Source(s) of Monetary Support: Japanese Gynecologic Oncology Group