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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031385
Receipt No. 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 2019/03/15

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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
Institute AstraZeneca K.K
Institute
Department

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 Enrolling by invitation
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
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.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


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