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

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 - A randomized phase III trial of AP versus DP, TC regimens for high risk group of endometrial carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000522

Enrollment

780

Registered

2006-11-15

Start date

2006-11-01

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

patients with high risk group of endometrial carcinoma which is removed surgically

Interventions

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

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 with the following either requirements by histologic diagnosis of primary lesion -stage I or II more than myometrial invasion 1/2, and grade 2 or 3 -stage III -stage IV without diatant metastasis to beyond the abdominal cavity 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 judged inappropriate for this study by the physicians

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
overall survival, toxicity, tolerability, status of lymphadenectomy	—

Countries

Japan

Contacts

Public ContactNobuyuki Susumu, M.D., Hiroyuki Nomura, M.D.

JGOG2043 Coordinating Office Department of Obstetrics and Gynecology, School of Medicine, Keio University

jgog2043@jgog.gr.jp03-3353-1211

Outcome results

None listed

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