UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021408
Receipt number R000024692
Scientific Title A randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432 (WJOG8415L)
Date of disclosure of the study information 2016/03/09
Last modified on 2024/03/15 09:14:36

* 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 randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432
(WJOG8415L)

Acronym

A randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432
(J-PLEURA)

Scientific Title

A randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432
(WJOG8415L)

Scientific Title:Acronym

A randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432
(J-PLEURA)

Region

Japan


Condition

Condition

Malignant pleural effusion

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare efficacy and safetiness of graded talc or OK-432 in the pleurodesis for malignant pleural effusions

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Pleural effusion relapse-free rate at Day 30 after pleurosesis

Key secondary outcomes

Pleural effusion relapse-free survival time, pleural effusion relapse-free survival rate in every 3 month, Quality of life, Side effects


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Instillation of OK-432 0.2KE/kg (max. 10KE) distilled in 50 mL of saline into thoracic cavity. Add another 50 mL of saline. After 2 hours, open drainage tube closure, use negative pressure pump. When the pleural effusion is under 150 mL/day, then the tube should be removed.

Interventions/Control_2

Instillation of graded talc 4g distilled in 50 mL of saline into thoracic cavity. Add another 50 mL of saline. After 2 hours, open drainage tube closure, use negative pressure pump. When the pleural effusion is under 150 mL/day, then the tube should be removed.

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) Histologically or cytologically proven malignant pleural effusion (original tumor should be lung cancer or gastrointestinal cancer)
2) To control dyspnea due to malignant pleural effusion and the procedure is the priority
3) To meet all the following criteria: malignant pleural effusion drainage is already done and,
a) The lung re-expanded by the drainage,
b) Symptom like dyspnea et al was improved by the drainage,
c) Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2,
d) SpO2 >= 90% in fresh air

4) Life expectancy <= 30 days after pleurodesis
5) Written informed consent from the patient

Key exclusion criteria

1) Hypersensitivity to talc or OK-432
2) Hypersensitivity to penicillin derivatives
3) Serious infection
4) Severe pulmonary emphysema or fibrosis
5) Treatment of heart failure
6) A history of myocardial infarction within 30 days of concent
7) Severe coagulopathy
8) Severe pleural adhesion
9) Requirement of bilateral simultaneous pleurodesis
10) A history of surgical procedure like lobectomy or total lung resection, in the affected lung
11) A history of pleurodesis on the affected side or contralateral side
12) Massive ascites
13) Systemic glucocorticosteroid (oral or intravenous), some reports revealed the possible negative effects on pleurodesis by the corticosteroids
14) Pregnant women, breast feeding women, potential pregnant women, women not intention to avoid pregnancy
15) Pshychiatric diorders
16) Not fit for this trial judged by the doctor in charge

Target sample size

300


Research contact person

Name of lead principal investigator

1st name chiyoe
Middle name
Last name kitagawa

Organization

Japanese National Hospital Organization, Nagoya Medical Center

Division name

Department of Respiratory Medicine, and Clinical Oncology

Zip code

460-0001

Address

4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Aichi, Japan

TEL

052-951-1111

Email

ckitag@kd6.so-net.ne.jp


Public contact

Name of contact person

1st name Shinichiro
Middle name
Last name Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

556-0016

Address

Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN

TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



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

National Hospital Organization Review Board for Clinical Trials (Nagoya)

Address

4-1-1 Sannomaru, Naka-ku,Nagoya, 460-0001 Aichi, JAPAN

Tel

052-951-1111

Email

hiranor@nnh.hosp.go.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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 09 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

300

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

No longer recruiting

Date of protocol fixation

2016 Year 03 Month 07 Day

Date of IRB

2016 Year 02 Month 24 Day

Anticipated trial start date

2016 Year 05 Month 20 Day

Last follow-up date

2023 Year 05 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 09 Day

Last modified on

2024 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024692


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name