UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000522 |
|---|---|
| Receipt number | 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 22:46:37 |
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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
| Obstetrics 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
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/
jgog2043@jgog.gr.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000628
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