UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016527 |
|---|---|
| Receipt number | R000018705 |
| Scientific Title | Intrapleural paclitaxel injection for ovarian and uterine cancer patients with malignant pleural effusions. |
| Date of disclosure of the study information | 2015/02/20 |
| Last modified on | 2019/08/26 12:17:51 |
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Basic information
Public title
Intrapleural paclitaxel injection for ovarian and uterine cancer patients with malignant pleural effusions.
Acronym
Intrapleural paclitaxel injection for malignant pleural effusions.
Scientific Title
Intrapleural paclitaxel injection for ovarian and uterine cancer patients with malignant pleural effusions.
Scientific Title:Acronym
Intrapleural paclitaxel injection for malignant pleural effusions.
Region
| Japan |
Condition
Condition
Refractory and recurrent Ovarian cancer and Endometrial cancer with pleural effusion
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this clinical trial is to investigate the treatment efficacy and safety of intrapleural paclitaxel injection in refractory and recurrent ovarian cancer and endometrial cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of mean drainage volume of pleural effusion between pre- and post-treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intrapleural injection of paclitaxel
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Age 20 and over
2. Patients with a ECOG Performance Status, (P.S.) of 0, 1, or 2
3. Patients must have normal bone marrow, cardiac, hepatic, hematologic, and renal function.
Must be obtained with 7 days prior to registration.
Granulocytes >= 1500/mm3
Platelets >= 100,000/mm3
Hemoglobin >= 9.0g/dL
Bilirubin <= 1.5mg/dL
Creatinine <= 1.2 mg/dL
4. Patients must have signed an approved informed consent.
Key exclusion criteria
1. Patients with active infection.
2. Patients with severe congestive heart failure, poorly controlled diabetes, poorly controlled hypertension, active bleeding etc.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemichi Watari |
Organization
Hokkaido University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5941
watarih@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidemichi Watari |
Organization
Hokkaido University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5941
Homepage URL
watarih@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine
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
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
| 2015 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 13 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018705
