UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022284
Receipt number R000025678
Scientific Title A prospective analysis of the efficacy and safety of complete surgery for advanced ovarian, fallopian tubal, primary peritneal cancer
Date of disclosure of the study information 2016/05/11
Last modified on 2016/05/11 21:28:34

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

Ovarian, fallopian tubal, primary peritneal 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, cancer.in this prospective study. 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 cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

overall survival

Key secondary outcomes

progression free survival
adverse event


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit

79 years-old >=

Gender

Female

Key inclusion criteria

1)Patients with clinical diagnosis of ovarian cancer, fallopian tube or primary peritoneal carcinoma
2)Patients who are 20 years old or older and younger than 79 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 paclitaxeal and carboplatin
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

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shozu Makio

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

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

School of Medicine, Chiba University

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

2016 Year 05 Month 11 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

2016 Year 05 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective analysis
1. Patients Charastarics
2. Contents of Aggressive surgery
3. Chemotherapy (Adjuvant or NAC)
4. adverse events
5. Outcome (progression free survival, overall survival)


Management information

Registered date

2016 Year 05 Month 11 Day

Last modified on

2016 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025678


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name