UMIN-CTR Clinical Trial

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
Email	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
Email	yohtakiadvanced@gmail.com

Sponsor
Institute	Division of General Thoracic Surgery, Integrative Center of General Surgery, Gunma University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032874