UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of local therapy including surgical resection in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Title of the study (Brief title)	Feasibility study of local therapy including surgical resection in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study evaluated the safety and efficacy of Salvage local therapy for the treatment in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1-year progression-free survival
Key secondary outcomes	2-year progression-free survival Overall Survival Safety Post operative Quality of life

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Operation Radiation
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytological proven clinical stage4 nonsmall cell carcinoma who receive induction systemic therapy. 2) Systemic therapy more than 12 months 3) Cases has a possibility of the radical cure resectability by lobectomy about the primary lesion at the maximum 4) Cases has a possibility of the radical therapy (surgery or radiation) about the metastatic lesion. 5) Adequate organ function. 6) Expected FEV 1.0 > 800ml after lung resection, SpO2 (Room air) >90% or PaO2 >= 65 torr. 7) Age >=20, <=75 y 8) ECOG PS 0-1 9) Cases indicating following organ (bone marrow, liver, kidney and lung) functions 10) Patients providing the written informed consent.
Key exclusion criteria	1) History of dissemination or malignant effusion. 2) Brain Metastasis with the severe symptom 3) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.) 4) History of active double cancer 5) History of active infection 6) Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp 7) History of continuous steroidal treatment or Immunosuppressive drug. 8) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Masafumi Kawamura
Organization	Teikyo University school of Medicine
Division name	Surgery
Address	2-11-1 Kaga, Itabashi-ku Tokyo
TEL	03-3964-1231
Email	mkawamur@med.teikyo-u.ac.jp

Public contact
Name of contact person	Hirofumi Uehara
Organization	Teikyo University school of Medicine
Division name	Surgery
Address	2-11-1 Kaga, Itabashi-ku Tokyo
TEL	03-3964-1231
Homepage URL
Email	hirofumi.uehara@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University school of Medicine
Institute
Department

Funding Source
Organization	Teikyo University school of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 01 Month 04 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 09 Day
Anticipated trial start date	2017 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 03 Day
Last modified on	2019 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029347