Unique ID issued by UMIN | UMIN000021408 |
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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 |
A randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432
(WJOG8415L)
A randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432
(J-PLEURA)
A randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432
(WJOG8415L)
A randomized comparative phase 3 trial of pleurodesis in malignant pleural effusions: sterile graded talc vs. OK-432
(J-PLEURA)
Japan |
Malignant pleural effusion
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To compare efficacy and safetiness of graded talc or OK-432 in the pleurodesis for malignant pleural effusions
Safety,Efficacy
Exploratory
Pragmatic
Phase III
Pleural effusion relapse-free rate at Day 30 after pleurosesis
Pleural effusion relapse-free survival time, pleural effusion relapse-free survival rate in every 3 month, Quality of life, Side effects
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
300
1st name | chiyoe |
Middle name | |
Last name | kitagawa |
Japanese National Hospital Organization, Nagoya Medical Center
Department of Respiratory Medicine, and Clinical Oncology
460-0001
4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Aichi, Japan
052-951-1111
ckitag@kd6.so-net.ne.jp
1st name | Shinichiro |
Middle name | |
Last name | Nakamura |
West Japan Oncology Group
WJOG datacenter
556-0016
Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
None
Self funding
National Hospital Organization Review Board for Clinical Trials (Nagoya)
4-1-1 Sannomaru, Naka-ku,Nagoya, 460-0001 Aichi, JAPAN
052-951-1111
hiranor@nnh.hosp.go.jp
NO
2016 | Year | 03 | Month | 09 | Day |
Unpublished
300
No longer recruiting
2016 | Year | 03 | Month | 07 | Day |
2016 | Year | 02 | Month | 24 | Day |
2016 | Year | 05 | Month | 20 | Day |
2023 | Year | 05 | Month | 10 | Day |
2023 | Year | 09 | Month | 30 | Day |
2016 | Year | 03 | Month | 09 | Day |
2024 | Year | 03 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024692
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