Endometrial carcinoma
Conditions
Interventions
TEC therapy Paclitaxel 150mg/m2 day 1 Epirubicin 50mg/m2 day 1 Carboplatin AUC=4 day 1 q.3 weeksx6 cycle
TAC therapy Paclitaxel 150mg/m2 day 2 Doxorubicin 45mg/m2 day 1 Carboplatin AUC=5 day
Sponsors
intergroup/GOGO
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed endometrial carcinoma 2)Hysterectomy, bilateral adnexectomy and pelvic lymphadenectomy are performed and a residual tumor size is less than 2cm 3)Endometrial carcinoma of the intermediate or high risk group (Table 1 in http://www.jsgo.gr.jp/guideline/img/e_taigan01.pdf) 4)No prior chamotherapy and radiotherapy for endomatrial carcinoma 5)At least 2 weeks since prior hormonal therapy 6)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 7)Within 8 weeks after the operation 8)More than 20 years old and less than 75 years old 9)Adequate bone marrow, hepatic, renal, cardiac and respiratory functions 10)Written informed consent
Exclusion criteria
Exclusion 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) Pregnant or lactating women 12)Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| completion rate of adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, OS, toxicity rate, response rate | — |
Countries
Japan
Contacts
Public ContactYUTAKA UEDA
Osaka University Graduate School of Mediciene Obstetrics and Gynecology
Outcome results
None listed