UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000116
Receipt number R000000172
Scientific Title randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection
Date of disclosure of the study information 2005/09/06
Last modified on 2019/01/29 18:06:35

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Basic information

Public title

randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection

Acronym

randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection

Scientific Title

randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection

Scientific Title:Acronym

randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for
stage IB-IIIA non small cell lung cancer after complete resection

Region

Japan


Condition

Condition

stage IB-IIIA non small cell lung cancer after complete resection

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the
post operative adjuvant chemotherapy for completely resected non-small cell
lung cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

overall survival

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

experimental arm: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6
cycle

Interventions/Control_2

standard arm: UFT 250mg/m2, daily for 1 year

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.completely resected non small cell lung cancer
2.no prior anti cancer treatment for thoracic malignancy exept for this
operation
3.pathological stage IB, II, and stage IIIA with only one station of n2
disease
4.PS 0-1
5.age 20-75
6.adequate oragan function for chemotherapy
7.written informed consent

Key exclusion criteria

1.small cell lung cancer or low grade malignancy of lung cancer
2.incomplete resection
3.apparant interstitial pneumonitis at chest rentogenogram
4.inadequate conditon for chemotherapy

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohito Tada, MD.

Organization

Osaka City General Hospital

Division name

Division of Thoracic Surgery

Zip code


Address

Miyakojima Hondhori 2-13-22

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address


TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



Funding Source

Organization

None

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

2005 Year 09 Month 06 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Main results already published

Date of protocol fixation

2001 Year 04 Month 28 Day

Date of IRB


Anticipated trial start date

2001 Year 06 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 09 Month 06 Day

Last modified on

2019 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000172


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name