UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054291 |
|---|---|
| Receipt number | R000062012 |
| Scientific Title | Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2024/05/01 11:42:07 |
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Basic information
Public title
Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study
Acronym
WJOG17123L
Scientific Title
Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study
Scientific Title:Acronym
WJOG17123L
Region
| Japan |
Condition
Condition
non-small cell lung cancer(non-squamous cell cancer)
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the therapeutic outcomes of postoperative adjuvant therapy in patients with EGFR gene mutation-positive non-small cell lung cancer through a prospective observational study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease-free survival
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-squamous non-small cell lung cancer
Pathological stage IA2 and high risk, or stage IA3, IB, IIA
Entire lesion diameter 5cm or less
Complete resection by lobectomy or segmentectomy
EGFR gene mutation has been confirmed
Postoperative adjuvant therapy with tegafur/uracil or osimertinib, or observation without treatment is planned.
18 years or older
ECOG performance status 0-1
Written consent has been obtained from the patient
Key exclusion criteria
Cases that fall under any of the following items will be excluded.
1) Have active multiple cancers*1
2) Have a local or systemic active infection that requires treatment
3) Pregnant women, lactating women, and women who may be currently pregnant.
4) Registration in this study is judged to be difficult due to a clinically problematic mental illness.
5) Receiving continuous systemic administration of steroids or immunosuppressants
6) Have a history of severe hypersensitivity
7) Exclusion provisions regarding complications
(a) Have a history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or have active ILD.
(b) Viral hepatitis
HBs antigen positive or HCV antibody positive
(c) HIV positive (however, negative confirmation by serum test is not required).
8) Other cases deemed inappropriate by the attending physician
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Keiju |
| Middle name | |
| Last name | Aokage |
Organization
National Cancer Center Hospital East
Division name
Division of Thoracic Surgery
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
0471331111
kaokage@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Miyoshi |
Organization
National Cancer Center Hospital East
Division name
Division of Thoracic Surgery
Zip code
2778577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
0471331111
Homepage URL
tmiyoshi@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Astrazenaca
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
IRB Office, National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel
0471331111
6-5-1, Kashiwanoha, Kashiwa, Chiba
Secondary IDs
Secondary IDs
YES
Study ID_1
WJOG17123L
Org. issuing International ID_1
West Japan Oncology Group
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2032 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062012
