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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008368
Receipt No. R000009837
Scientific Title Adjuvant Chemotherapy for Endometrial cancer Trial: A randomised phase II study of TEC, TAC and ddTC for endometrial carcinoma
Date of disclosure of the study information 2012/09/01
Last modified on 2012/09/13

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Basic information
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
Condition Endometrial carcinoma with risk factors of recurrence.
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes PFS, completion rate of chemotherapy
Key secondary outcomes OS, side effects, 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)(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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Gynecologic Oncology Group of Osaka (GOGO)
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2012 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2012 Year 07 Month 06 Day
Last modified on
2012 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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