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

Adjuvant Chemotherapy for Endometrial cancer Trial: A randomised phase II study of TEC, TAC and ddTC for endometrial carcinoma - ACE trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008368

Enrollment

Registered

2012-09-01

Start date

2012-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial carcinoma with risk factors of recurrence.

Interventions

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) eve

Eligibility

Sex/Gender

Female

Inclusion criteria

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 <FIGO stage I or II> -G3, myometrial invasion<=1/2 -G1, G2, G3, myometrial invasion>1/2 -cervical stromal invasion -serous or clear adneocarcinoma, undifferentiated carcinoma <FIGO stage III or IV> -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 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)patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant 12)Patients judged inappropriate for this study by the physicians

Design outcomes

Primary

Measure	Time frame
PFS, completion rate of chemotherapy	—

Secondary

Measure	Time frame
OS, side effects, response rate	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026