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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025503
Receipt No. R000029347
Scientific 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
Date of disclosure of the study information 2017/01/04
Last modified on 2019/01/05

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Basic information
Public 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
Acronym Feasibility study of local therapy including surgical resection in patients with clinical stageIV non-small cell lung cancer (NSCLC) who receive induction systemic therapy
Scientific 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Masafumi Kawamura
Organization Teikyo University school of Medicine
Division name Surgery
Zip code
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
1st name
Middle name
Last name Hirofumi Uehara
Organization Teikyo University school of Medicine
Division name Surgery
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 09 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000029347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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