UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008911 |
|---|---|
| Receipt number | R000010442 |
| Scientific Title | A randomized phase II study of TEC (Paclitaxel+Epirubicin+Carboplatin) therapy, TAC (Paclitaxel+Doxorubicin+Carboplatin)therapy, and ddTC (Dose-dense Paclitaxel+Carboplatin) therapy as adjuvant chemotherapy for the patients with intermediate or high risk group of endometrial carcinoma |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2022/03/22 15:41:57 |
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Basic information
Public title
A randomized phase II study of
TEC (Paclitaxel+Epirubicin+Carboplatin) therapy,
TAC (Paclitaxel+Doxorubicin+Carboplatin)therapy, and
ddTC (Dose-dense Paclitaxel+Carboplatin) therapy
as adjuvant chemotherapy for the patients with intermediate or high risk group of endometrial carcinoma
Acronym
ACE trial
(GOGO-EM3 / Intergroup Study)
Scientific Title
A randomized phase II study of
TEC (Paclitaxel+Epirubicin+Carboplatin) therapy,
TAC (Paclitaxel+Doxorubicin+Carboplatin)therapy, and
ddTC (Dose-dense Paclitaxel+Carboplatin) therapy
as adjuvant chemotherapy for the patients with intermediate or high risk group of endometrial carcinoma
Scientific Title:Acronym
ACE trial
(GOGO-EM3 / Intergroup Study)
Region
| Japan |
Condition
Condition
Endometrial carcinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the safety and efficacy of TEC therapy, TAC therapy and dose dense TC therapy as adjuvant chemotherapy for endometrial carcinoma cases with intermediate or high risk to select the most appropriate regimen for a further phase III study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
completion rate of adjuvant chemotherapy
Key secondary outcomes
PFS, OS, toxicity rate, response rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TEC therapy
Paclitaxel 150mg/m2 day 1
Epirubicin 50mg/m2 day 1
Carboplatin AUC=4 day 1
q.3 weeksx6 cycle
Interventions/Control_2
TAC therapy
Paclitaxel 150mg/m2 day 2
Doxorubicin 45mg/m2 day 1
Carboplatin AUC=5 day 2
q.3 weeksx6 cycle
Interventions/Control_3
ddTC therapy
Paclitaxel 80mg/m2 day 1,8,15
Carboplatin AUC 5 day 1
q.3 weeksx6 cycle
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 of the intermediate or high risk group
(Table 1 in http://www.jsgo.gr.jp/guideline/img/e_taigan01.pdf)
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) Pregnant or lactating women
12)Patients judged inappropriate for this study by the physicians
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | YUTAKA |
| Middle name | |
| Last name | UEDA |
Organization
Osaka University Graduate School of Mediciene
Division name
Obstetrics and Gynecology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, osaka 565-0871, Japan
TEL
06-6879-3351
ZVF03563@nifty.ne.jp
Public contact
Name of contact person
| 1st name | YUTAKA |
| Middle name | |
| Last name | UEDA |
Organization
Osaka University Graduate School of Mediciene
Division name
Obstetrics and Gynecology
Zip code
565-0871
Address
2-2 Yamakdaoka, Suita, Osaka
TEL
06-6879-3351
Homepage URL
ZVF03563@nifty.ne.jp
Sponsor or person
Institute
intergroup/GOGO
Institute
Department
Personal name
Funding Source
Organization
GOGO
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
2-15 Yamadaoka. Suira
Tel
06-6879-3351
zvf03563@nifty.ne.jp
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
インターグループ参加施設、その他の施設
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.dmi.med.osaka-u.ac.jp/acr/index.html
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/cas.15310
Number of participants that the trial has enrolled
105
Results
Compete rate of
paclitaxel-epirubicin-carboplatin (TEC), paclitaxel-anthracycline (doxorubicin)-carboplatin (TAC), or dose-dense paclitaxel-carboplatin (ddTC) was 94%, 64%, and 69%, respectively (P = .005).
Results date posted
| 2022 | Year | 03 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No significant difference
Participant flow
Randomization after registration
Adverse events
No significant difference
Outcome measures
Compete rate of chemotherapy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 13 | Day |
Last modified on
| 2022 | 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=R000010442
