UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043937 |
|---|---|
| Receipt number | R000050165 |
| Scientific Title | Multicenter prospective observational study for adjuvant chemotherapy using the eighth edition lung cancer TNM classification and clinical staging system (ILO1804) |
| Date of disclosure of the study information | 2021/04/16 |
| Last modified on | 2023/10/17 16:31:24 |
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Basic information
Public title
Multicenter prospective observational study for adjuvant chemotherapy using the eighth edition lung cancer TNM classification and clinical staging system (ILO1804)
Acronym
Multicenter prospective observational study for adjuvant chemotherapy using the eighth edition lung cancer TNM classification and clinical staging system (ILO1804)
Scientific Title
Multicenter prospective observational study for adjuvant chemotherapy using the eighth edition lung cancer TNM classification and clinical staging system (ILO1804)
Scientific Title:Acronym
Multicenter prospective observational study for adjuvant chemotherapy using the eighth edition lung cancer TNM classification and clinical staging system (ILO1804)
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the outcome of adjuvant chemotherapy based on the 8th edition TNM classification for patients with non-small cell lung cancer in Japan, and to inspect the feasibility of conducting prospective randomized controlled study by estimating the optimal indication of adjuvant chemotherapy according to molecular profiling (EGFR status and PD-L1 expression).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3 year and 5 year disease free survival survival after surgery
Key secondary outcomes
1)3 year and 5 year overall survival after surgery
2)Adjuvant chemotherapy implementation rate
3)Outcomes by genetic mutation or PD-L1 expression
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Non-small cell lung cancer
2)Tumor size >2cm
3)R0
4)Standard surgical treatment was performed
5)Lymph node dissection or Lymph node sampling were performed
6)No treatment prior to surgery
7)Performance status (ECOG) 0-1
8)Sufficient organ function (Bone marrow, Liver, Kidney, Lung)
9)Within 56 days after surgery
Key exclusion criteria
1) The patients had tumors where genetic testing cannot be performed for some reason (insufficient sample volume, etc.
2) Active double cancer, excluding the following curable cases even if the disease-free period is within 5 years; carcinoma in situ or mucosal cancer, prostate cancer (stage I), gastric cancer (stage 0-I), colorectal cancer (stage 0-I), esophageal cancer (stage 0), breast cancer (stage 0), thyroid cancer (papillary or follicular cancer, stage I-III), renal cancer (clear cell carcinoma or chromophobe cell cancer, stage I).
3) The patients were dead within 30 days after surgery.
4) The patients were pregnant or breastfeeding, and the patients may be pregnant, or will be pregnant, or willing to get pregnant.
5) The patients were difficult to participate in the study because of psychosis and/or mental illness.
6) The patients had grade 3 or higher adverse events
7) The attending physician judged that it was inappropriate for the patient to participate in the study.
8) The patients refused to participate in the study.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | YUICHI |
| Middle name | Saito |
| Last name | SAITO |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
173-8605
Address
Kaga 2-11-1, Itabashi-ku, Tokyo
TEL
0339641211
yuichi.saito@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | YUICHI |
| Middle name | |
| Last name | SAITO |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
173-8605
Address
Kaga 2-11-1, Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
k3699004@gmail.com
Sponsor or person
Institute
International Lung-clinical-Research Organization
Institute
Department
Personal name
Funding Source
Organization
International Lung-clinical-Research Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University School of Medicine
Address
Kaga 2-11-1, Itabashi-ku, Tokyo
Tel
03-3964-1211
k3699004@gmail.com
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
山形大学附属病院（山形県）、山形県立中央病院（山形県）、獨協医科大学附属病院（栃木県）、埼玉県立循環器呼吸器病センター（埼玉県）、埼玉医科大学附属総合医療センター（埼玉県）、東京歯科大学附属市川病院（千葉県）、帝京大学附属病院（東京都）、帝京大学付属溝口病院（神奈川県）、北里大学附属病院（神奈川県）、横浜市立大学附属病院（神奈川県）、神奈川県立がんセンター（神奈川）、関東労災病院（神奈川県）、湘南鎌倉総合病院（神奈川県）、浜松医科大学付属病院（静岡県）、浜松医療センター（静岡県）、奈良県立医科大学付属病院（奈良県）、石切生喜病院（大阪）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 16 | 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
962
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Factors that will be registered>
Age, Gender, Smoking history, Date of surgery, Surgical procedure, Resected site, Pathological stage TNM 8th edition), Histology, Tumor size, Invasive size, Grade of histology, Pleural lavage cytology, v, ly, pl, pm, Spread through alveolar space, Immunohistochemistry (PD-L1 expression etc.), EGFR mutation, ALK fusion gene status, ROS1 fusion gene status, BRAF mutation, Adjuvant chemotherapy (presence or absence, start day, regimen, cycle), Survival confirmation day, Recurrence (presence or absence, confirmation day, site of recurrence), Death day, Cause of death, Recurrence treatment (agents, cycle, effect assessment)
Management information
Registered date
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050165
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/10/17 | ILO1804_計画書ver4（帝京大学）_20230808.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/10/17 | revised02_ILO1804_CRF.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/10/17 | ver05_統合_ILO1804_CRF_20241017.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/50165
