A randomized phase II study of TEC (Paclitaxel+Epirubicin+Carboplatin) therapy, TAC (Paclitaxel+Doxorubicin+Carboplatin)therapy, and ddTC (Dose-dense Paclitaxel+Carboplatin) therapy as adjuvant chemotherapy for the patients with intermediate or high risk group of endometrial carcinoma
- Conditions
- Endometrial carcinoma
- Registration Number
- JPRN-UMIN000008911
- Lead Sponsor
- intergroup/GOGO
- Brief Summary
Compete rate of paclitaxel-epirubicin-carboplatin (TEC), paclitaxel-anthracycline (doxorubicin)-carboplatin (TAC), or dose-dense paclitaxel-carboplatin (ddTC) was 94%, 64%, and 69%, respectively (P = .005).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 105
Not provided
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) Pregnant or lactating women 12)Patients judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method completion rate of adjuvant chemotherapy
- Secondary Outcome Measures
Name Time Method PFS, OS, toxicity rate, response rate