UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028741 |
|---|---|
| Receipt number | R000032874 |
| Scientific Title | A multicenter retrospective study on efficacy and safety of salvage surgery for primary lung cancer |
| Date of disclosure of the study information | 2017/08/21 |
| Last modified on | 2019/07/04 05:51:15 |
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Basic information
Public title
A multicenter retrospective study on efficacy and safety of salvage surgery for primary lung cancer
Acronym
A multicenter retrospective study on efficacy and safety of salvage surgery for primary lung cancer
Scientific Title
A multicenter retrospective study on efficacy and safety of salvage surgery for primary lung cancer
Scientific Title:Acronym
A multicenter retrospective study on efficacy and safety of salvage surgery for primary lung cancer
Region
| Japan |
Condition
Condition
primary lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the efficacy and safety of salvage surgery for remnant or recurernce of primary lung cancer after definitive radiation/ definitive chemoradiotherapy/ stereotactic radiotherapy, ion radiotherapy/ molecular targeted therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3-year overall survival rate
Key secondary outcomes
Adverse event, Incidence of complications, Perioperative mortality, 3-year recurrence free survival rate, Median survival time
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A) Patient who underwent salvage surgery after
definitive CRT/RT, stereotactic radiation, ion beam therapy.
1) Patient who underwent salvage surgery between 1/1/2010 and 12/31/2015.
2) Primary lung cancer was proven pathologically at any point in time.
3) Patient who could not complete the initial therapy because of adverse event or complication is also eligible, if the initial therapy was intended radical treatment.
4) Three years passed after salvage surgery.
B) Patient who underwent salvage surgery after molecular targeted therapy(EGFR-TKI or ALK inhibitor).
1) Patient who underwent salvage surgery between 1/1/2010 and 12/31/2015.
2) Primary lung cancer was proven pathologically at any point in time.
3) EGFR-TKI or ALK inhibitor was administrated.
4) Three years passed after salvage surgery.
5) EGFR mutation status and ALK rearrangement status do not matter.
Key exclusion criteria
1) Patient treated as induction therapy intentionally.
2) Patient who underwent resection not for local lesion (other than lung or regional lymph node).
3) Patient who was treated with molecular targeted therapy other than EGFR-TKI or ALK inhibitor as molecular targeted therapy.
4) Patient who withdrew the consent of this study.
5) Patient who was considered inappropriate to this study by attending doctor.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiro Shimizu |
Organization
Gunma University Hospital
Division name
Division of General Thoracic Surgery, Integrative Center of General Surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8245
kmshimizu@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Ohtaki, Kimihiro Shimizu |
Organization
Gunma University Hospital
Division name
Division of General Thoracic Surgery, Integrative Center of General Surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8245
Homepage URL
yohtakiadvanced@gmail.com
Sponsor or person
Institute
Division of General Thoracic Surgery, Integrative Center of General Surgery, Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association for Chest Surgery
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
群馬大学医学部付属病院（群馬）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 21 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: multicenter retrospective observational study using central registration system
Registration method: Electronic Data Capture system
Management information
Registered date
| 2017 | Year | 08 | Month | 19 | Day |
Last modified on
| 2019 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032874
