UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013079
Receipt number R000015259
Scientific Title A retrospective analysis of the efficacy and safety of complete surgery for advanced ovarian, fallopian tubal, primary peritneal, uterus corpus cancer
Date of disclosure of the study information 2014/02/05
Last modified on 2014/02/05 12:22:49

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Basic information

Public title

A retrospective analysis of the efficacy and safety of complete surgery for advanced ovarian, fallopian tubal, primary peritneal, uterus corpus cancer

Acronym

A retrospective analysis of the efficacy and safety of complete surgery for advanced ovarian, fallopian tubal, primary peritneal, uterus corpus cancer

Scientific Title

A retrospective analysis of the efficacy and safety of complete surgery for advanced ovarian, fallopian tubal, primary peritneal, uterus corpus cancer

Scientific Title:Acronym

A retrospective analysis of the efficacy and safety of complete surgery for advanced ovarian, fallopian tubal, primary peritneal, uterus corpus cancer

Region

Japan


Condition

Condition

ovarian, fallopian tubal, primary peritneal, uterus corpus cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the efficacy and safety of complete surgery for advanced ovarian, fallopian tubal, primary peritneal, uterus corpus cancer. If the complete surgery contribute to good prognosis and less adverse effect for each patients, we can had one optional treatment for advanced ovarian, fallopian tubal, primary peritneal, uterus corpus cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression free survival,toxicity

Key secondary outcomes

overall survival


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

operation,chemotherpy

Interventions/Control_2


Interventions/Control_3


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

25 years-old <=

Age-upper limit

80 years-old >

Gender

Female

Key inclusion criteria

1)Patients with a histological diagnosis of ovarian cancer (including fallopian tube, or primary peritoneal carcinoma) and uterus corpus cancer
2)Patients who are 20 years old or older and younger than 80 years old at the enrollment
3)Performance status:ECOG 0-2
4)Adequate bone marrow, renal, and hepatic function
5)Patients who are expected to survive more than 3 months.
6)Patients who have signed an approved informed consent.

Key exclusion criteria

1)Patients who have a history of hypersensitivity to gemcitabine and irinotecan.
2)Patients with active infection
3)Patients with severe complications (Heart disease, uncontrolleddiabetes, malignant hypertension, or bleeding tendency)
4)Patients with other cancer within the past 5 years
5)Patients with myocardial infarction within 6 months or angina attack.
6)Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Tate , M.D.

Organization

Chiba University Hospital

Division name

Department of Gynecology

Zip code


Address

1-8-1 Inohana Chuo Chiba Japan

TEL

043-222-7171

Email

state@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Tate , M.D.

Organization

Chiba University Hospital

Division name

Department of Gynecology

Zip code


Address

1-8-1 Inohana Chuo Chiba Japan

TEL

043-222-7171

Homepage URL


Email

state@faculty.chiba-u.jp


Sponsor or person

Institute

School of Medicine, Chiba University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2014 Year 02 Month 05 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

Open public recruiting

Date of protocol fixation

2014 Year 02 Month 05 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 05 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

2014 Year 02 Month 05 Day

Last modified on

2014 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015259


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name