UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047443 |
|---|---|
| Receipt number | R000054097 |
| Scientific Title | The Impact of EGFR Mutation on Adjuvant Chemotherapy with UFT for Patients with Completely Resected, Non-Lymph Node Metastatic Non-Small Cell Lung Cancer (>2 cm): A Multicenter, Retrospective, Observational Study as Secondary Analysis of CSPOR-LC03 Study |
| Date of disclosure of the study information | 2022/04/08 |
| Last modified on | 2022/04/08 15:13:02 |
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Basic information
Public title
The Impact of EGFR Mutation on Adjuvant Chemotherapy with UFT for Patients with Completely Resected, Non-Lymph Node Metastatic Non-Small Cell Lung Cancer (>2 cm): A Multicenter, Retrospective, Observational Study as Secondary Analysis of CSPOR-LC03 Study
Acronym
The Impact of EGFR Mutation on Adjuvant Chemotherapy with UFT for Patients with Completely Resected, Non-Lymph Node Metastatic Non-Small Cell Lung Cancer (>2 cm): A Multicenter, Retrospective, Observational Study as Secondary Analysis of CSPOR-LC03 Study
Scientific Title
The Impact of EGFR Mutation on Adjuvant Chemotherapy with UFT for Patients with Completely Resected, Non-Lymph Node Metastatic Non-Small Cell Lung Cancer (>2 cm): A Multicenter, Retrospective, Observational Study as Secondary Analysis of CSPOR-LC03 Study
Scientific Title:Acronym
The Impact of EGFR Mutation on Adjuvant Chemotherapy with UFT for Patients with Completely Resected, Non-Lymph Node Metastatic Non-Small Cell Lung Cancer (>2 cm): A Multicenter, Retrospective, Observational Study as Secondary Analysis of CSPOR-LC03 Study
Region
| Japan |
Condition
Condition
Completely resected, non-lymph node metastatic non-small cell lung cancer (>2 cm)
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the effect of EGFR mutation in the presence of adjuvant UFT chemotherapy in some cohorts of a large-scale retrospective multicenter observational study (CSPOR-LC03 study), which investigated the actual status of adjuvant chemotherapy after lung cancer surgery in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year recurrence-free survival (RFS) rate
Key secondary outcomes
5-year overall survival (OS) rate
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
In the CSPOR-LC03 study, data from 5005 patients with completely resected NSCLC were collected from 34 institutions in Japan. These patients were diagnosed as Pathological Stage I (T1>2 cm, TNM Classification 6th edition) and underwent lobectomy or more extensive surgical resection plus ND2a or more extensive lymphadenectomy during the period from the start month of each institution to December 31, 2013, but were not enrolled in the JCOG0707 study. By retrospective analysis of patient demographic characteristics, tumor profiles, and post-operative treatments, 2599 patients were classified as patients "who were eligible for the JCOG0707 study but were not actually enrolled." Of the 2599 patients, 74 patients were excluded because whether they received adjuvant UFT therapy was unknown, and the remaining 2525 patients will be the subjects of this observational study.
Key exclusion criteria
Patients whose status of use of adjuvant chemotherapy is unknown.
Target sample size
2599
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsuboi |
Organization
National Cancer Center Hospital East
Division name
Division of Thoracic Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.
TEL
04-7133-1111
cspor-lc03add@csp.or.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Miyoshi |
Organization
Observational Study as Secondary Analysis of CSPOR-LC03 Study Coordinating Office
Division name
Division of Thoracic Surgery, National Cancer Center Hospital East
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.
TEL
04-7133-1111
Homepage URL
cspor-lc03add@csp.or.jp
Sponsor or person
Institute
Comprehensive Support Project for Oncology Research (CSPOR), Public Health Research Foundation
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
No
Name of secondary funder(s)
No
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan.
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 08 | 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
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter, retrospective, cohort study
For study subjects, the CRF information from the CSPOR-LC03 study will be used. In addition, for 1493 patients whose EGFR mutation status is unknown, additional EGFR mutation testing with surgical specimens will be performed using the cobas EGFR Mutation Test v2. From the cases we encountered previously, we assume that about 45% of the 1493 patients have EGFR mutations. In addition, we will construct a new database by collecting pathological reports of all subjects, and perform retrospective analysis.
(1) Using the patient data from the cohort of those "eligible but not enrolled in the JCOG0707 study" in the CSPOR-LC03 study, the impact of the status of EGFR mutation on the prognosis will be investigated according to the presence or absence of adjuvant UFT chemotherapy. This study aims to clarify whether the status of EGFR mutation is a predictor of treatment response to adjuvant UFT therapy and is a prognostic factor.
(2) By performing univariate and multivariate analyses, identify prognostic factors for recurrence and death, using clinicopathological factors, including the presence or absence of EGFR mutation. Then, analyze the interaction between EGFR mutation and UFT therapy.
(3) For RFS and OS, perform subgroup analysis based on the pathological stage and the presence or absence of a ground-glass opacity (GGO) lesion.
(4) In each of the patient groups with and without adjuvant UFT chemotherapy, clinicopathological characteristics will be analyzed according to the presence or absence of EGFR mutation.
Management information
Registered date
| 2022 | Year | 04 | Month | 08 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054097
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