Unique ID issued by UMIN | UMIN000031385 |
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Receipt number | R000035768 |
Scientific Title | Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study) |
Date of disclosure of the study information | 2018/02/20 |
Last modified on | 2020/02/18 18:18:35 |
Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)
Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)
Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)
Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)
Japan |
Stage III non-small cell lung cancer
Pneumology | Chest surgery | Radiology |
Malignancy
NO
[1st cohort: clinical stage III NSCLC patients who have received curative chemoradiotherapy]
The objectives of the 1st cohort are to demonstrate treatment reality in clinical practice by investigating prognosis and safety profile in terms of adverse events including pneumonitis and radiation pneumonitis by initial treatment regimen in clinical practice in patients with unresectable stage III NSCLC who have received curative chemoradiotherapy.
[2nd cohort: whole clinical stage III NSCLC patients]
The objectives of the 2nd cohort are to demonstrate treatment reality in clinical practice by investigating prognosis and safety profile in terms of adverse events including pneumonitis and radiation pneumonitis by type of initial treatment in clinical practice in whole patients with clinical stage III NSCLC who have received any aggressive treatment.
Others
Retrospective observational study
Not applicable
[1st cohort]
1.To estimate OS in the overall cohort population
[2nd cohort]
2.To estimate OS in the overall cohort population
[1st cohort]
1.To estimate PFS in the overall cohort populations and OS and PFS by treatment regimen
2.To estimate ORR and TTDM in the overall cohort populations and by treatment regimen
3.To evaluate safety profile of treatment for patients with stage III NSCLC in terms of treatment-related adverse events including pneumonitis/radiation pneumonitis
4.To summarize treatment outcomes stratified by clinical characteristics
[2nd cohort]
5.To summarize the patient characteristics at initial diagnosis in overall cohort population and in type of initial treatments
6.To estimate OS, PFS, and DFS (in case of surgery) in type of initial treatment
7.To estimate ORR and TTDM in type of initial treatment, without surgery
8.To evaluate safety profile of treatment for patients with stage III NSCLC in terms of treatment-related adverse events including pneumonitis/radiation pneumonitis
9.To summarize treatment outcomes stratified by clinical characteristics
Observational
20 | years-old | <= |
Not applicable |
Male and Female
[1st cohort]
1.Patients giving written informed consent to participate in this study (for patients who have died or been lost to follow up, the instructions of the ERB in each medical institution [e.g., general consent and opt-out] should be followed)
2.Male or female patients aged 20 years or older at the time of diagnosis of stage III NSCLC
3.Patients diagnosed with unresectable stage III NSCLC between January 1 2013 and December 31 2015
4.Patients who were received curative chemoradiotherapy including platinum (the patients diagnosed as unresectable who were received the salvage surgery after chemoradiotherapy are eligible)
[2nd cohort]
5.Patients giving written informed consent to participate in this study (for patients who have died or been lost to follow up, the instructions of the ERB in each medical institution [e.g., general consent and opt-out] should be followed)
6.Male or female patients aged 20 years or older at the time of diagnosis of stage III NSCLC
7.Patients diagnosed with stage III NSCLC between January 1 2013 and December 31 2014
8.Patients who were received any aggressive treatment without supportive care or no treatment
1. Patients receiving unapproved drugs for the treatment of NSCLC at the initiation of this study
2. Patients who are regarded as inappropriate to participate in the study by the primary investigators
1000
1st name | |
Middle name | |
Last name | Shigetaka Kouda |
AstraZeneca K.K
Medical Evidence & Observational Research Medical
Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka
06-7711-3714
Shigetaka.Kouda@astrazeneca.com
1st name | |
Middle name | |
Last name | Satomi Kohata |
A2 Healthcare Corporation
Clinical Research Department
1-4-1, Koishikawa, Bunkyo-ku, Tokyo
03-3830-1075
SOLUTION@a2healthcare.com
AstraZeneca K.K
AstraZeneca K.K.
Profit organization
NO
静岡県立静岡がんセンター(静岡県)、独立行政法人国立病院機構姫路医療センター(兵庫県)、独立行政法人国立病院機構近畿中央胸部疾患センター(大阪府)、久留米大学(福岡県)、独立行政法人国立病院機構京都医療センター(京都府)、独立行政法人国立病院機構山口宇部医療センター(山口県)、独立行政法人国立病院機構北海道がんセンター(北海道)、独立行政法人国立病院機構四国がんセンター(愛媛県)、日本医科大学付属病院(東京都)、金沢大学附属病院(石川県)、国立研究開発法人国立がん研究センター中央病院(東京都)、岡山大学病院(岡山県)
2018 | Year | 02 | Month | 20 | Day |
Unpublished
Completed
2017 | Year | 12 | Month | 15 | Day |
2018 | Year | 01 | Month | 12 | Day |
2018 | Year | 03 | Month | 13 | Day |
2019 | Year | 09 | Month | 30 | Day |
2019 | Year | 10 | Month | 31 | Day |
2019 | Year | 10 | Month | 31 | Day |
(Observational study)
Demographics
Smoking history
Pulmonary function testing
EGFR mutation
ALK translocation
PD-L1 expression
Diagnostic information
Performance status (PS)
Comorbidities
-By initial treatment
-Effect of first-line therapy
-Chemotherapy after first-line therapy
-Surgical history after first-line therapy
-Radiotherapy history after first-line therapy
Safety information on stage III NSCLC treatment
Clinical outcome
2018 | Year | 02 | Month | 20 | Day |
2020 | Year | 02 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035768
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