UMIN-CTR Clinical Trial

Public title

Adjuvant Chemotherapy for Endometrial cancer Trial:
A randomised phase II study of TEC, TAC and ddTC for endometrial carcinoma

Acronym

ACE trial

Scientific Title

Adjuvant Chemotherapy for Endometrial cancer Trial:
A randomised phase II study of TEC, TAC and ddTC for endometrial carcinoma

Scientific Title:Acronym

ACE trial

Region

Japan

Condition

Endometrial carcinoma with risk factors of recurrence.

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

A randomized comparison of TEC, TAC and ddTC for endometrial carcinoma with risk factors of recurrence.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

PFS, completion rate of chemotherapy

Key secondary outcomes

OS, side effects, response rate

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TEC therapy
Paclitaxel (150mg/m2)(day1)
Epirubicin (50mg/m2)(day1)
CBDCA (AUC=4)(day1)
every 3 weeks

Interventions/Control_2

TAC therpay
Paclitaxel (150mg/m2)(day2)
Doxorubicin (45mg/m2)(day1)
CBDCA (AUC=5)(day2)
every 3 weeks

Interventions/Control_3

ddTC therapy
Paclitaxel (80mg/m2)(day1,8,15)
CBDCA (AUC=5)(day1,8,15)
every 3 weeks

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Female

Key inclusion criteria

1)Histologically confirmed endometrial carcinoma
2)At least hysterectomy, bilateral adnexectomy and pelvic lymphadenectomy are performed and a residual tumor size is equal to or less than 2cm
3)Endometrial carcinoma with the following either requirements by histologic diagnosis of primary lesion
<FIGO stage I or II>
-G3, myometrial invasion<=1/2
-G1, G2, G3, myometrial invasion>1/2
-cervical stromal invasion
-serous or clear adneocarcinoma, undifferentiated carcinoma
<FIGO stage III or IV>
-spread to adnexa, serosa, cardinal ligament
-invasion to vaginal wall
-metastasis to pelvic or para-aortic lymphnode
-Vesical or rectal invasion
-peritoneal dissemination
-distant metastasis
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 who are pregnant, lactating, possibly pregnant, or planning to become pregnant
12)Patients judged inappropriate for this study by the physicians

Target sample size

90

Name of lead principal investigator

1st name
Middle name
Last name	Yutaka Ueda

Organization

Osaka University Graduate School of Medicine

Division name

Obstetrics and Gynecology

Zip code

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Medicine

Division name

Obstetrics and Gynecology

Zip code

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

Homepage URL

Email

Institute

Gynecologic Oncology Group of Osaka (GOGO)

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2012

Year

07

Month

10

Day

Date of IRB

Anticipated trial start date

2012

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

07

Month

06

Day

Last modified on

2012

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009837