A randomized phase III trial of AP(Doxorubicin+Cisplatin) versus DP(Docetaxel+Cisplatin), TC(Paclitaxel+Carboplatin) as adjuvant chemotherrapy in patients with high risk group of endometrial carcinoma

UMIN ID: UMIN000000522

Registered date:15/11/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: patients with high risk group of endometrial carcinoma which is removed surgically
• Date of first enrollment: 2006/11/01
• Target sample size: 780
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Doxorubicin 60 mg/m2 + CDDP 50 mg/m2 day 1 q 3 weeks 6 courses
Docetaxel 70 mg/m2 + CDDP 60 mg/m2 day 1 q 3 weeks 6 courses
Paclitaxel 180 mg/m2 + CBDCA AUC 6 day 1 q 3 weeks 6 courses

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: overall survival, toxicity, tolerability, status of lymphadenectomy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1)Patients with sarcomatous element 2)Active infections 3)Serious complications (heart disease, uncontrolled diabetes mellitus, malignant hypertension and tendency to bleeding) 4)Active concomitant malignancy 5)Interstitial pneumonitis and plumonary fibrosis 6)Massive pleural effusion or ascites 7)Neuropathy grade 2 or more (NCI-CTC) 8)Edema grade 2 or more (NCI-CTC) 9)prior chemotherapy including doxorubicin 10)Hypersensitivity to Polysorbate 80 or Cremophor EL 11)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