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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016527
Receipt No. 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

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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
Obsterics 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
Email 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
Email watarih@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018705

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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