NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000522

Registered date:15/11/2006

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpatients with high risk group of endometrial carcinoma which is removed surgically
Date of first enrollment2006/11/01
Target sample size780
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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

Outcome(s)

Primary OutcomeProgression-free survival
Secondary Outcomeoverall survival, toxicity, tolerability, status of lymphadenectomy

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderFemale
Include criteria
Exclude criteria1)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

Related Information

Contact

public contact
Name Nobuyuki Susumu, M.D., Hiroyuki Nomura, M.D.
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan Japan
Telephone 03-3353-1211
E-mail jgog2043@jgog.gr.jp
Affiliation JGOG2043 Coordinating Office Department of Obstetrics and Gynecology, School of Medicine, Keio University
scientific contact
Name Daisuke Aoki, M.D.
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan Japan
Telephone 03-3353-1211
E-mail jgog2043@jgog.gr.jp
Affiliation School of Medicine, Keio University Department of Obstetrics and Gynecology