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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037078
Receipt No. R000042249
Scientific Title Retrospective analysis of complete remission in cases with advanced non-small cell lung cancer
Date of disclosure of the study information 2019/06/18
Last modified on 2019/06/16

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Basic information
Public title Retrospective analysis of complete remission in cases with advanced non-small cell lung cancer
Acronym Retrospective analysis of complete remission in cases with advanced non-small cell lung cancer
Scientific Title Retrospective analysis of complete remission in cases with advanced non-small cell lung cancer
Scientific Title:Acronym Retrospective analysis of complete remission in cases with advanced non-small cell lung cancer
Region
Japan

Condition
Condition stage III and IV non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to identify features of complete remission cases in stage III and IV advanced non-small cell lung cancer by analyzing long-term survivors whose overall survival exceeded 3 years.
Basic objectives2 Others
Basic objectives -Others The aim of this study is to identify features of complete remission cases in stage III and IV advanced non-small cell lung cancer by analyzing patient characteristics, tumor characteristics, and treatment contents and modalities among long-term survivors whose overall survival exceeded 3 years.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome of interest is the overall survival of all eligible NSCLC patients.
Key secondary outcomes The secondary endpoints are patient characteristics, tumor characteristics, and treatment contents and modalities in long-term survivors, whose overall survival exceeded 3 years, and complete remission patients.

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
99 years-old >=
Gender Male and Female
Key inclusion criteria The study eligibility criteria for patients were as follows: stage III or IV (The International Association for the Study of Lung Cancer: IASLC 8th edition of the TNM classification for lung cancer), histologically or cytologically confirmed NSCLC, and first chemotherapy or EGFR-TKI administration had been initiated between 1st Mar 2004 and 30th Apr 2011.
Key exclusion criteria No exclusion criteria
Target sample size 443

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Aoki
Organization Tokai University School of Medicine
Division name Respiratory Division, Department of Internal Medicine
Zip code 259-1193
Address 143 Shimokasuya, Isehara City, Kanagawa, Japan
TEL 0463-93-1121
Email aokitaku@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Aoki
Organization Tokai University School of Medicine
Division name Respiratory Division, Department of Internal Medicine
Zip code 259-1193
Address 143 Shimokasuya, Isehara City, Kanagawa, Japan
TEL 0463-93-1121
Homepage URL
Email aokitaku@is.icc.u-tokai.ac.jp

Sponsor
Institute Respiratory Division, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department

Funding Source
Organization This work was partially supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI (Grant Number JP16K09555 [to Takuya Aoki]).
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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 東海大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 18 Day

Related information
URL releasing protocol http://irb.med.u-tokai.ac.jp/images/poster/2014/14R227.pdf
Publication of results Partially published

Result
URL related to results and publications https://s3.amazonaws.com/iaslc/pdf/WCLC2018-Abstract-Book_Web.pdf
Number of participants that the trial has enrolled 443
Results
There were 164 stage III and 279 stage IV patients, with 37 (22.6%) and 51 (18.3%) long-term survivors and 12 (7.3%) and 5 (1.8%) complete remission (CR) patients, respectively. The cured stage IV patients had smaller primary tumors and fewer metastases at initial diagnoses. 
Results date posted
2019 Year 06 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From our hospital database, 1,699 patients were registered as having lung cancer between 1st Mar 2004 and 30th Apr 2011, and 164 stage III and 279 stage IV patients who met the eligibility criteria were enrolled. The median age of stage III patients was 68 years (range 41-88), and these patients were older than the stage IV patients (65 years; range 32-89). 
Participant flow
The proportion of males in the stage III group was larger than that in the stage IV group. Regarding histological types, the proportion of squamous cell carcinoma was highest among stage III patients, while the proportion of adenocarcinoma was highest among stage IV patients.
Adverse events
Not applicable
Outcome measures
The cured stage IV patients had smaller primary tumors and fewer metastases at initial diagnoses. All cured stage III patients received chemoradiation.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 06 Month 03 Day
Date of IRB
2014 Year 06 Month 30 Day
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2017 Year 02 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information There were 164 stage III and 279 stage IV patients, who were analyzed.

Management information
Registered date
2019 Year 06 Month 16 Day
Last modified on
2019 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042249

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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