UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031385
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

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Basic information

Public title

Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)

Acronym

Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)

Scientific Title

Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)

Scientific Title:Acronym

Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)

Region

Japan


Condition

Condition

Stage III non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

[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.

Basic objectives2

Others

Basic objectives -Others

Retrospective observational study

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

[1st cohort]
1.To estimate OS in the overall cohort population
[2nd cohort]
2.To estimate OS in the overall cohort population

Key secondary outcomes

[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


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

[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

Key exclusion criteria

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

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigetaka Kouda

Organization

AstraZeneca K.K

Division name

Medical Evidence & Observational Research Medical

Zip code


Address

Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka

TEL

06-7711-3714

Email

Shigetaka.Kouda@astrazeneca.com


Public contact

Name of contact person

1st name
Middle name
Last name Satomi Kohata

Organization

A2 Healthcare Corporation

Division name

Clinical Research Department

Zip code


Address

1-4-1, Koishikawa, Bunkyo-ku, Tokyo

TEL

03-3830-1075

Homepage URL


Email

SOLUTION@a2healthcare.com


Sponsor or person

Institute

AstraZeneca K.K

Institute

Department

Personal name



Funding Source

Organization

AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

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)


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 15 Day

Date of IRB

2018 Year 01 Month 12 Day

Anticipated trial start date

2018 Year 03 Month 13 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry

2019 Year 10 Month 31 Day

Date trial data considered complete

2019 Year 10 Month 31 Day

Date analysis concluded



Other

Other related information

(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


Management information

Registered date

2018 Year 02 Month 20 Day

Last modified on

2020 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035768


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name