UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025503
Receipt number 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 09:05:17

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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 or person

Institute

Teikyo University school of Medicine

Institute

Department

Personal name



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

Value
https://center6.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