A phase II randomized study of DP(Docetaxel+Cisplatin),DJ(Docetaxel+Carboplatin),and TJ(Paclitaxel+Carboplatin) in patients with advanced and recurrent endometrial carcinoma

UMIN ID: C000000170

Registered date:15/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced or recurrent endometrial carcinoma
• Date of first enrollment: 2003/12/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Docetaxel 70mg/m2+CDDP 60mg/m2 day1 q 3 weeks 3courses or more
Docetaxel 60mg/m2+CBDCA AUC 6 day1 q 3 weeks 3courses or more
Paclitaxel 180mg/m2+CBDCA AUC 6 day1 q 3 weeks 3courses or more

Outcome(s)

• Primary Outcome: Tumor Response
• Secondary Outcome: Toxicity, Feasibility, Progression free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: -Patients with sarcomatous element -Active infections -Serious complications (heart disease, interstitial lung disease, uncontrolled hypertension, diabetes mellitus and tendency to bleeding) -Massive pleural effusion or ascites -Neuropathy grade 2 or more; edema grade 2 or more (NCI-CTC) -Active concomitant malignancy -Hypersensitivity to Polysorbate 80 or Cremophor EL -Patients judged inappropriate for this study by the physicians

Related Information

• Primary Sponsor: Japanese Gynecologic Oncology Group
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare,Japanese Gynecologic Oncology Group