UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis
Title of the study (Brief title)	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	KATAOKA Yuki
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine, Hospital Care Research Unit
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	KATAOKA Yuki
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine, Hospital Care Research Unit
Address	Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.
TEL	06-6480-7000
Homepage URL
Email	hanshin.crt@gmail.com

Sponsor
Institute	Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.haigan.gr.jp/journal/am/2015a/15a_gpl31000P-184.html
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021017