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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
