UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037078 |
|---|---|
| Receipt number | 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 00:05:32 |
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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
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
aokitaku@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Respiratory Division, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042249
