UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	ZVF03563@nifty.ne.jp

Sponsor
Institute	intergroup/GOGO
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010442