UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective analysis of the efficacy and safety of complete surgery for advanced ovarian, fallopian tubal, primary peritneal cancer
Title of the study (Brief title)	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	Obsterics 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shozu Makio
Organization	Chiba University Hospital
Division name	Department of Gynecology
Address	1-8-1 Inohana Chuo Chiba Japan
TEL	043-222-7171
Email	state@faculty.chiba-u.jp

Public contact
Name of contact person	Shinichi Tate
Organization	Chiba University Hospital
Division name	Department of Gynecology
Address	1-8-1 Inohana Chuo Chiba Japan
TEL	043-222-7171
Homepage URL
Email	state@faculty.chiba-u.jp

Sponsor
Institute	School of Medicine, Chiba University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025678