UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006022
Receipt number R000007112
Scientific Title Induction chemoradiotherapy followed by surgery without mediastinal lymphnode disection in stage IIIA(bulkyN2)/IIIB non-small cell lung cancer
Date of disclosure of the study information 2011/07/31
Last modified on 2015/01/22 11:59:00

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Basic information

Public title

Induction chemoradiotherapy followed by surgery without mediastinal lymphnode disection in stage IIIA(bulkyN2)/IIIB non-small cell lung cancer

Acronym

Induction chemoradiotherapy followed by surgery without mediastinal lymphnode disection in stage IIIA(bulkyN2)/IIIB non-small cell lung cancer

Scientific Title

Induction chemoradiotherapy followed by surgery without mediastinal lymphnode disection in stage IIIA(bulkyN2)/IIIB non-small cell lung cancer

Scientific Title:Acronym

Induction chemoradiotherapy followed by surgery without mediastinal lymphnode disection in stage IIIA(bulkyN2)/IIIB non-small cell lung cancer

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Feasibility of induction chemoradiotherapy followed by surgery without mediastinal lymphnode disection in stage IIIA(bulkyN2) /IIIB non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Feasibility

Key secondary outcomes

OS, PFS, efficacy of induction chemoradiotherapy, severe adverse effects of surgery.


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

Induction chemoradiotherapy followed by surgery without mediastinal lymphnode disection in stage IIIA(bulkyN2) /IIIB non-small cell lung cancer

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

15 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically confirmed non-small cell lung cancer.
2)Stage IIIA(bulkyN2)/IIIB lung cancer.
3)No prior treatment
4)Resectable primary tumor.
5)More than 16 years old-less than 75 years old.
6)PS0-1
7)At least one or more measurable lesion by RECIST.
8)Adequate organ function.
9)Written Informed Consent.

Key exclusion criteria

1)Active co-morbidities.
2)Interstitial lung disease.
3)Active infection.
4)Severe heart disease.
5)Contralateral hilar lymphnode metastasis
6)Neurological disorder.
7)Active double cancer.
8)Psychotic disorder.
9)Histology of grave allergic reaction.
10)Pregnancy, breast feeding and supected pregnancy.
11)Patients whose participation in the trial is judged to be inappropriate.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiki Hirata

Organization

Iseikai Hospital

Division name

Respiratory Disease Center

Zip code


Address

6-2-25 Sugawara, Higashiyodogawa-ku, Osaka City, 533-0022, Japan.

TEL

06-6326-1121

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Iseikai Hospital

Division name

Respiratory Disease Center

Zip code


Address


TEL

06-6326-1121

Homepage URL


Email



Sponsor or person

Institute

Iseikai Hospital

Institute

Department

Personal name



Funding Source

Organization

Iseikai Hospital

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

2011 Year 07 Month 31 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

Terminated

Date of protocol fixation

2011 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date

2014 Year 08 Month 01 Day

Date of closure to data entry

2014 Year 08 Month 01 Day

Date trial data considered complete

2014 Year 08 Month 01 Day

Date analysis concluded

2014 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 07 Month 22 Day

Last modified on

2015 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007112


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name