UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of talc poudrage for patients with malignant pleural effusions
Acronym	A phase II study of talc poudrage for patients with malignant pleural effusions
Scientific Title	A phase II study of talc poudrage for patients with malignant pleural effusions
Scientific Title:Acronym	A phase II study of talc poudrage for patients with malignant pleural effusions
Region	Japan

Condition
Condition	malignant pleural effusion
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of talc poudrage for malignant pleural effusion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Pleural effusion control rate 30 days after talc poudrage.
Key secondary outcomes	Pain, pyrexia, oxygen saturation, and flow rate of oxygen after talc poudrage. Adverse effect. Time to reccurence of pleural effusion.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pleurodesis with talc poudrage (4g).
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	Male and Female
Key inclusion criteria	1. Malignant pleural effusion confirmed by histopathology or cytology. 2. Symptomatic with malignant pleural effusion and needs intervention. 3. Relief of symptoms is expected with drainage of pleural effusion. 4. Life expectancy of 30 days or more. 5. ECOG PS is expected to be 0-2 after darainage of pleural effusion. 6. 20 years of age or older. 7. Written informed consent from patient is gained.
Key exclusion criteria	1. Hypersensitivity to talc. 2. Hypersensitivity to lidocaine hydrochrolide. 3. Severe infection. 4. Severe hypoxemia despite oxgen therapy. 5. Uncontrolled angina or heart failure. 6. Myocardical infarction within 30 days of consent. 7. Severe bleeding diathesis. INR > 2.0 or platelet <60000/mm3. 8. Severe pleural adhesion. 9. Indication for bilateral pleurodesis. 10. History of pleurodeis of affected side. 11. Preganant or during lactation. Patient who hopes to bear child, or who can not keep contraceptive maneuver. 12. Inappropriate to enter this trial judged by the physician in charge
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kenya Middle name Last name Yoshida
Organization	Nishichita General Hospital
Division name	Department of Repiratory Medicine
Zip code	4778522
Address	Nakanoike3-1-1, Tokai-shi, Aichi-ken
TEL	0562-33-5500
Email	kenyayoshida@minos.ocn.ne.jp

Public contact
Name of contact person	1st name Kenya Middle name Last name Yoshida
Organization	Nishichita General Hospital
Division name	Department of Repiratory Medicine
Zip code	4778522
Address	Nakanoike3-1-1, Tokai-shi, Aichi-ken
TEL	0562-33-5500
Homepage URL
Email	kenyayoshida@minos.ocn.ne.jp

Sponsor
Institute	Nishichita General Hospital
Institute
Department

Funding Source
Organization	None
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	Nishichita General Hospital
Address	Nakanoike3-1-1, Tokai-shi, Aichi-ken
Tel	0562-33-5500
Email	ngh@nishichita-hp.aichi.jp

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	公立西知多総合病院（愛知県）

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 14 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	7
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 06 Month 26 Day
Date of IRB	2014 Year 07 Month 09 Day
Anticipated trial start date	2014 Year 07 Month 14 Day
Last follow-up date	2019 Year 08 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 14 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016930