UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000522
Receipt No. R000000628
Scientific Title 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
Date of disclosure of the study information 2006/11/15
Last modified on 2019/03/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym A randomized phase III trial of AP versus DP, TC regimens for high risk group of endometrial carcinoma
Scientific Title 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
Scientific Title:Acronym A randomized phase III trial of AP versus DP, TC regimens for high risk group of endometrial carcinoma
Region
Japan

Condition
Condition patients with high risk group of endometrial carcinoma which is removed surgically
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose is to compare the progression-free survival (PFS) of AP regimen as adjuvant chemotherapy with that of DP regimen and that of TC regimen for high risk group of endometrial carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes overall survival, toxicity, tolerability, status of lymphadenectomy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Doxorubicin 60 mg/m2 + CDDP 50 mg/m2 day 1 q 3 weeks
6 courses
Interventions/Control_2 Docetaxel 70 mg/m2 + CDDP 60 mg/m2 day 1 q 3 weeks
6 courses
Interventions/Control_3 Paclitaxel 180 mg/m2 + CBDCA AUC 6 day 1 q 3 weeks
6 courses
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Female
Key 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
Key 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
Target sample size 780

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Aoki, M.D.
Organization School of Medicine, Keio University
Division name Department of Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL 03-3353-1211
Email jgog2043@jgog.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Susumu, M.D., Hiroyuki Nomura, M.D.
Organization JGOG2043 Coordinating Office
Division name Department of Obstetrics and Gynecology, School of Medicine, Keio University
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL 03-3353-1211
Homepage URL http://www.jgog.gr.jp/
Email jgog2043@jgog.gr.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Japanese Gynecologic Oncology Group

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 11 Month 15 Day

Related information
URL releasing protocol https://www.jgog.gr.jp/
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30896757
Number of participants that the trial has enrolled 788
Results
https://www.ncbi.nlm.nih.gov/pubmed/30896757
Results date posted
2019 Year 03 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://www.ncbi.nlm.nih.gov/pubmed/30896757
Participant flow
https://www.ncbi.nlm.nih.gov/pubmed/30896757
Adverse events
https://www.ncbi.nlm.nih.gov/pubmed/30896757
Outcome measures
https://www.ncbi.nlm.nih.gov/pubmed/30896757
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2016 Year 01 Month 01 Day
Date of closure to data entry
2016 Year 01 Month 01 Day
Date trial data considered complete
2017 Year 10 Month 01 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 11 Month 15 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000628

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.