UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019370
Receipt number R000022395
Scientific Title Prospective observational study for advanced lung cancer with interstitial lung disease
Date of disclosure of the study information 2015/11/01
Last modified on 2022/10/20 09:23:51

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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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022395


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name