UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study for advanced lung cancer with interstitial lung disease
Acronym	Advanced lung cancer with interstitial lung disease
Scientific Title	Prospective observational study for advanced lung cancer with interstitial lung disease
Scientific Title:Acronym	Advanced lung cancer with interstitial lung disease
Region	Japan

Condition
Condition	Advanced lung cancer with interstitial lung disease
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Prospective observation for the clinical course and prognosis of advanced lung cancer patients with interstitial lung disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety, particulary for the frequency and severity of chemotherapy-induced acute exacerbation of interstitial lung disease
Key secondary outcomes	Efficacy including response rate and progression-free survival

Base
Study type	Observational

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	1. Diagnosed with primary lung cancer with histopathological evidence 2. Chemotherapy-naiive 3. Advanced clinical stage without indication for curative surgery and radiotherapy 4. Preexisting interstitial lung disease on chest computed tomography at the time of lung cancer diagnosis 5. Written informed consent
Key exclusion criteria	1. Post-radiation fibrosis alone
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Suda
Organization	Hamamatsu University School of Medicine
Division name	Second division, Department of internal medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
TEL	+8153-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Yasunori Middle name Last name Enomoto
Organization	Hamamatsu University School of Medicine
Division name	Second division, Department of internal medicine
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
TEL	+8153-435-2263
Homepage URL
Email	enomotoy@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
Tel	+8153-435-2680
Email	rinri@hama-med.ac.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	浜松医科大学付属病院、聖隷三方原病院、聖隷浜松病院、遠州病院、天竜病院、浜松労災病院、浜松日赤病院、浜松医療センター、磐田市立病院、藤枝市立総合病院、静岡市立静岡病院、静岡市立清水病院、静岡日赤病院、静岡県立総合病院、静岡済生会総合病院

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 01 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9243372/
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9243372/
Number of participants that the trial has enrolled	124
Results	Among 124 patients enrolled, 109 patients who received chemotherapy were analyzed. After registration, 23 patients developed AE-ILD. The logistic analysis revealed that lower %FVC significantly increased the risk of AE-ILD. Overall response rates/median overall survival times in non-small-cell lung cancer and small-cell lung cancer for the first-line chemotherapy were 41%/8.9 months and 91%/12.2 months, respectively.
Results date posted	2022 Year 10 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The median age was 72 years, and 68.8% showed UIP/probable UIP pattern upon chest CT. The median percent-predicted forced vital capacity was 81%.
Participant flow	Among 124 patients, 109 received 1st-line chemotherapy. After that, 64/109 received 2nd-line and 17/64 received 3rd-line.
Adverse events	None.
Outcome measures	After registration, 23 patients developed AE-ILD. The logistic analysis revealed that lower %FVC significantly increased the risk of AE-ILD. Overall response rates/median overall survival times in non-small-cell lung cancer and small-cell lung cancer for the first-line chemotherapy were 41%/8.9 months and 91%/12.2 months, respectively.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 11 Month 01 Day
Date of IRB	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Design: Cohort study (multiinstitutional prospective observational study) Subjects: Patients, diagnosed with lung cancer and interstitial lung disease between November 2015 and September 2020, who fulfill our inclusion criteria Evaluation items: Pretreatment examination data such as laboratory tests (KL-6, SP-D, LDH, CRP), pulmonary function tests, and computed tomography; efficacy and safety of chemotherapy; prognosis

Management information
Registered date	2015 Year 10 Month 15 Day
Last modified on	2022 Year 10 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022395