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 |
Prospective observational study for advanced lung cancer with interstitial lung disease
Advanced lung cancer with interstitial lung disease
Prospective observational study for advanced lung cancer with interstitial lung disease
Advanced lung cancer with interstitial lung disease
Japan |
Advanced lung cancer with interstitial lung disease
Pneumology |
Malignancy
NO
Prospective observation for the clinical course and prognosis of advanced lung cancer patients with interstitial lung disease
Safety,Efficacy
Safety, particulary for the frequency and severity of chemotherapy-induced acute exacerbation of interstitial lung disease
Efficacy including response rate and progression-free survival
Observational
Not applicable |
Not applicable |
Male and Female
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
1. Post-radiation fibrosis alone
300
1st name | Takafumi |
Middle name | |
Last name | Suda |
Hamamatsu University School of Medicine
Second division, Department of internal medicine
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
+8153-435-2263
suda@hama-med.ac.jp
1st name | Yasunori |
Middle name | |
Last name | Enomoto |
Hamamatsu University School of Medicine
Second division, Department of internal medicine
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
+8153-435-2263
enomotoy@hama-med.ac.jp
Hamamatsu University School of Medicine
none
Self funding
Hamamatsu University School of Medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
+8153-435-2680
rinri@hama-med.ac.jp
NO
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
2015 | Year | 11 | Month | 01 | Day |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9243372/
Published
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9243372/
124
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.
2022 | Year | 10 | Month | 20 | Day |
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%.
Among 124 patients, 109 received 1st-line chemotherapy. After that, 64/109 received 2nd-line and 17/64 received 3rd-line.
None.
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.
Main results already published
2015 | Year | 11 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
2015 | Year | 11 | Month | 01 | Day |
2020 | Year | 10 | Month | 31 | Day |
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
2015 | Year | 10 | Month | 15 | Day |
2022 | Year | 10 | Month | 20 | Day |
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 |