UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018145
Receipt number R000021017
Scientific Title Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis
Date of disclosure of the study information 2015/07/01
Last modified on 2016/12/31 09:08:39

* 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

Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis

Acronym

Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis

Scientific Title

Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis

Scientific Title:Acronym

Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis

Region

Japan


Condition

Condition

advanced non-small cell lung cancer with interstitial lung disease

Classification by specialty

Medicine in general Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The research question of this review is: what are the clinical effectiveness and safety of chemotherapy for treating NSCLC with ILD ?

Basic objectives2

Others

Basic objectives -Others

Sytematic review and mata-analysis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

One year survival

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with interstitial lung disease and suffering from non small cell lung cancer.
Treated with chemotherapy.

Key exclusion criteria

treated with epidermal growth factor receptor tyrosine-kinase inhibitor

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name KATAOKA Yuki

Organization

Hyogo Prefectural Amagasaki General Medical Center

Division name

Department of Respiratory Medicine, Hospital Care Research Unit

Zip code


Address

Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.

TEL

06-6480-7000

Email

hanshin.crt@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name KATAOKA Yuki

Organization

Hyogo Prefectural Amagasaki General Medical Center

Division name

Department of Respiratory Medicine, Hospital Care Research Unit

Zip code


Address

Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.

TEL

06-6480-7000

Homepage URL


Email

hanshin.crt@gmail.com


Sponsor or person

Institute

Hyogo Prefectural Amagasaki General Medical Center

Institute

Department

Personal name



Funding Source

Organization

Hyogo Prefectural Amagasaki General Medical Center

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 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.haigan.gr.jp/journal/am/2015a/15a_gpl31000P-184.html

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

2015 Year 04 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Searches
The full search strategy is not required, but may be supplied as a link or attachment.
We sill search the following electronic databases; 1. MEDLINE; 2. EMBASE via SCOPUS; 3. Cochrane library; 4. ICHUSHI Web; In addition we will searche the following websites: 1. ClinicalTrials.gov 2. the World Health Organization International Clinical Trials Platform Search Portal ( ICTRP) All relevant studies published as an article, and country of origin will be included. We will exclude studies reporting on < 10 participants.



Types of study to be included initially
irrespective of types of study design (observational or interventional)

Primary outcome(s)
One year survival
Measured by proportion of the total number of patients dying from any cause within one year after the initiation of therapy.
Secondary outcomes
Acute excercerbation of ILD during the study period
AE-ILD was defined by original authors. Measured by proportion of the total number of patients suffered AE-ILD during the study period.

Data extraction, (selection and coding)
Give the procedure for selecting studies for the review and extracting data, including the number of researchers involved and how discrepancies will be resolved. List the data to be extracted.

Risk of bias (quality) assessment
Two authors independently will assess risk of bias used the Newcastle-Ottawa scale for observational studies and the Cochrane risk of bias table for interventional studies . Agreement between the two review authors with regard to the primary outcomes and the risk of bias items will be reported as percentage agreement and weighted kappa. Disagreement will be resolved by discussion and if necessary a third review author involved.

Strategy for data synthesis
We will pool the relative risk (RR) with 95% confidence interval (CI) for the following binary outcomes.

Analysis of subgroups or subsets
None planned


Management information

Registered date

2015 Year 07 Month 01 Day

Last modified on

2016 Year 12 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021017


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name