UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007790
Receipt number R000009180
Scientific Title A randomized trial of adjuvant chemotherapy in resected stage I lung adenocarcinoma with high SUV index. JNETS 1201
Date of disclosure of the study information 2012/04/20
Last modified on 2014/03/04 15:37:27

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Basic information

Public title

A randomized trial of adjuvant chemotherapy in resected stage I lung adenocarcinoma with high SUV index. JNETS 1201

Acronym

Adjuvant chemotherapy in lung adenocarcinoma with high SUV index. JNETS 1201

Scientific Title

A randomized trial of adjuvant chemotherapy in resected stage I lung adenocarcinoma with high SUV index. JNETS 1201

Scientific Title:Acronym

Adjuvant chemotherapy in lung adenocarcinoma with high SUV index. JNETS 1201

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of adjuvant chemotherapy for resected stage I lung adenocarcinoma with high SUV index.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Disease-free survival


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Control n=230(stage IA: no chemotherapy, stage IB: UFT)

Interventions/Control_2

Trial n=230 (stage IA: UFT, stage IB: chemotherapy with CDDP or CBDCA)

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

76 years-old >

Gender

Male and Female

Key inclusion criteria

p-stage I lung adenocarcinoma with SUV index with 1 or more.

Key exclusion criteria

non-p-stage I lung adenocarcinoma with SUV index with 1 or more.

Target sample size

460


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Kondo

Organization

Tohoku University, school of medicine

Division name

Department of thoracic surgery,

Zip code


Address

4-1, Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-8526

Email



Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Shiono

Organization

Yamagata Prefectural Central Hospital

Division name

Department of thoracic surgery

Zip code


Address

1800, Ooazaaoyagi, Yamagata

TEL

023-685-2626

Homepage URL


Email



Sponsor or person

Institute

Japanese Northern East Area Thoracic Surgery Study Group (JNETS-SG)

Institute

Department

Personal name



Funding Source

Organization

Japanese Northern East Area Thoracic Surgery Study Group (JNETS-SG)

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

2012 Year 04 Month 20 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

2012 Year 03 Month 29 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2020 Year 04 Month 01 Day

Date of closure to data entry

2020 Year 04 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 19 Day

Last modified on

2014 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009180


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name