Adjuvant Chemotherapy for Endometrial cancer Trial: a randomised phase II study of TEC, TAC and ddTC for endometrial carcinoma

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: TEC therapy Paclitaxel (150mg/m2)(day1) Epirubicin (50mg/m2)(day1) CBDCA (AUC=4)(day1) every 3 weeks TAC therpay Paclitaxel (150mg/m2)(day2) Doxorubicin (45mg/m2)(day1) CBDCA (AUC=5)(day2) every 3 weeks ddTC therapy Paclitaxel (80mg/m2)(day1,8,15) CBDCA (AUC=5)(day1,8,15) every 3 weeks CONDITION: Endometrial carcinoma with risk factors of recurrence. PRIMARY OUTCOME: PFS, completion rate of chemotherapy SECONDARY OUTCOME: OS, side effects, response rate INCLUSION CRITERIA: 1)Histologically confirmed endometrial carcinoma 2)At least hysterectomy, bilateral adnexectomy and pelvic lymphadenectomy are performed and a residual tumor size is equal to or less than 2cm 3)Endometrial carcinoma with the following either requirements by histologic diagnosis of primary lesion ‐G3, myometrial invasion<=1/2 ‐G1, G2, G3, myometrial invasion>1/2 ‐cervical stromal invasion ‐serous or clear adneocarcinoma, undifferentiated carcinoma ‐spread to adnexa, serosa, cardinal ligament ‐invasion to vaginal wall ‐metastasis to pelvic or para‐aortic lymphnode ‐Vesical or rectal invasion ‐peritoneal dissemination ‐distant metastasis 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 th
Epistemonikos ID: c3a5f0e64cf6a852a7a8a8f9f224d660dd9b9653
First added on: Aug 22, 2024