UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023102 |
|---|---|
| Receipt number | R000026319 |
| Scientific Title | Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial. |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2017/05/17 15:45:26 |
* 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
Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial.
Acronym
NHOK-HypoCis
Scientific Title
Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial.
Scientific Title:Acronym
NHOK-HypoCis
Region
| Japan |
Condition
Condition
Interstitial pneumonia merger stage IV non-small cell lung cancer case with the malignant pleural effusion
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The pleural effusion control rate (30days after administration of hypotonic cisplatin for malignant pleural effusion)
Key secondary outcomes
Proportion of acute exacerbation of intestinal lung disease,overall survival,
pleural effusion free progression free survival, Toxicities
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
Multicenter, single-arm, open-label trial
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) cytologically or histologically proven non-small cell lung cancer
2) cytologically or histologically proven malignant pleural effusion ,which had been untreated
3) Non-treatment case for non-small cell lung cancer or systemic treatment had been administered at least 31 days more before entry
4) dyspnea prior to chest tube drainage
5)a full expansion of lung obtained by chest tube drainage
6) Eligible patients were aged between 20 and 80 years
7) Eastern Cooperative Oncology Group(ECOG)PS 0-2
8) intestinal lung disease examined by computed tomography.(Intestinal lung diseases involve IPF,NSIP,DIP,RB-ILD, collagen vascular disease with intestinal lung disease and asbestosis related intestinal lung disease. AIP and COP were excluded)
9)life expectancy >= 30days
10)Written informed consent were obtained from the patient
11)14 days before entry, the following laboratory values
were required:
a leukocyte count>= 3000mm^3
a platelet count >= 100000mm^3
alanine aminotransferase < 100IU/l
asparate aminotransferase< 100IU/l
a serum creatinine level<= 1.5mg/dl
Key exclusion criteria
Exclusion criteria were as follows
1) All 1-3 were found within 30 days or possibility of acute exacerbation of intestinal lung disease.
1. worsening of respiratory distress
2. emerging ground grass attenuation or consolidation of the lung by computed tomography
3. worsening of PaO2 >= 10Torr
2) lung cancer had not been treated within 30 days
3) active double cancer
4) allergic reaction for lidocaine
5) carcinomatous pericarditis
6) uncontrolled heart failure
7) myocardial infarction within 30days
8) unstable angina pectoris
9) active infectious diseases
10) drug allery>= Grade3
11) Pregnancy, lactating woman, women of childbearing potential and patients not intend to prevent pregnancy
12) allergic pulmonary disorders or acute exacerbation of intestinal lung diseases
13) surgical treatment had previously been done for thorax in the malignant effusion
14) steroid usage (predonine >= 5mg)
15) SpO2 <90(under room air)
16) physician assessed that patients are not adequate for this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Omachi |
Organization
National Hospital Organization Kinki -Chuo Medical Center
Division name
clinical oncology
Zip code
Address
1180, Nagasonecho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3021
nomachi@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiko Kobayashi |
Organization
National Hospital Organization Kinki -Chuo Medical Center
Division name
Medicine in general
Zip code
Address
1180, Nagasonecho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3021
Homepage URL
t-kobayashi@kch.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kinki -Chuo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 07 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2017 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
