UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054053 |
|---|---|
| Receipt number | R000061710 |
| Scientific Title | A real-world observational study evaluating efficacy and safety of neoadjuvant chemo-immunotherapy in patients with resectable non-small cell lung cancer (Neo FACT) |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2024/04/03 17:15:43 |
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Basic information
Public title
A real-world observational study evaluating efficacy and safety of neoadjuvant chemo-immunotherapy in patients with resectable non-small cell lung cancer (Neo FACT)
Acronym
A real-world observational study evaluating efficacy and safety of neoadjuvant chemo-immunotherapy in patients with resectable non-small cell lung cancer (Neo FACT)
Scientific Title
A real-world observational study evaluating efficacy and safety of neoadjuvant chemo-immunotherapy in patients with resectable non-small cell lung cancer (Neo FACT)
Scientific Title:Acronym
A real-world observational study evaluating efficacy and safety of neoadjuvant chemo-immunotherapy in patients with resectable non-small cell lung cancer (Neo FACT)
Region
| Japan |
Condition
Condition
Resectable clinical stage IIA-IIIB non-small cell lung cancer receiving neoadjuvant chemo-immunotherapy
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this trial are to elucidate the efficacy and safety of neoadjuvant chemo-immunotherapy for resectable non-small cell lung cancer in real-world clinical settings, as well as to explore the feasibility of sublobar resection for well-responded cases to neoadjuvant chemo-immunotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of feasible cases for sublobar resection (segmentectomy or wedge resection) based on preoperative imaging findings
Key secondary outcomes
Proportion of feasible cases for sublobar resection (segmentectomy or wedge resection) based on intraoperative findings
Concordance of feasibility of sublobar resection between preoperative imaging and intraoperative findings
Concordance of treatment efficacy between preoperative and pathological findings
Concordance of treatment efficacy between primary lesion and involved lymph nodes
Clinicopathological characteristics of feasible cases for sublobar resection
Completion rate of preoperative treatment
Complete resection rate
Pathological response rate
Rate of adverse events
Overall survival
Event-free survival
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
Cohort 1: Patients with clinical stage IIA-IIIB non-small cell lung cancer who are scheduled to receive neoadjuvant chemo-immunotherapy from the date of study approval until March 31, 2027.
Cohort 2: Patients with clinical stage IIA-IIIB non-small cell lung cancer who have received or are receiving neoadjuvant chemo-immunotherapy between June 2017 and the date of study approval.
Key exclusion criteria
For both Cohorts 1 and 2:
1. Patients deemed inappropriate by the principal investigator.
2. Patients under the age of 18 at the time of surgery.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Morihito |
| Middle name | |
| Last name | Okada |
Organization
Hiroshima University
Division name
Department of Surgical Oncology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5869
morihito@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kamigaichi |
Organization
Hiroshima University
Division name
Department of Surgical Oncology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5869
Homepage URL
akamigaichi23@gmail.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-5555
iryo-sinsa@office.hiroshima-u.ac.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
広島大学病院 （広島県）
近畿大学病院（大阪府）
沖縄病院（沖縄県）
北九州市立医療センター（福岡県）
静岡がんセンター（静岡県）
国立がん研究センター東病院（千葉県）
順天堂大学医学部附属順天堂医院（東京都）
聖マリアンナ医科大学病院（神奈川県）
東北大学病院（宮城県）
東京医科大学病院（東京都）
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Study design: Multicenter, prospective and retrospective observational study
2. Outcome measures:
Proportion of feasible cases for sublobar resection (segmentectomy or wedge resection) based on preoperative imaging findings
Proportion of feasible cases for sublobar resection (segmentectomy or wedge resection) based on intraoperative findings
Concordance of feasibility of sublobar resection between preoperative imaging and intraoperative findings
Concordance of treatment efficacy between preoperative and pathological findings
Concordance of treatment efficacy between primary lesion and involved lymph nodes
Clinicopathological characteristics of feasible cases for sublobar resection
Completion rate of preoperative treatment
Complete resection rate
Pathological response rate
Rate of adverse events
Overall survival
Event-free survival
Management information
Registered date
| 2024 | Year | 04 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061710
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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