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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010442


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name