UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001263
Receipt number R000001537
Scientific Title Does gefitinib prolong the survival of adenocarcinoma patients against non-adeno non-small cell lung cancer? A retrospective study.
Date of disclosure of the study information 2008/07/23
Last modified on 2015/08/31 16:09:57

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Basic information

Public title

Does gefitinib prolong the survival of adenocarcinoma patients against non-adeno non-small cell lung cancer? A retrospective study.

Acronym

A retrospective survival analysis of patients in non-small cell lung cancer.

Scientific Title

Does gefitinib prolong the survival of adenocarcinoma patients against non-adeno non-small cell lung cancer? A retrospective study.

Scientific Title:Acronym

A retrospective survival analysis of patients in non-small cell lung cancer.

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess whether the prognosis of the adenocarcinoma patients is different from non-adenocarcinoma in advanced non-small cell lung cancer retrospectively.

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Overall survival

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Advanced non-small cell lung cancer patients who treated with initial chemotherapy during Junuary 1st 2004 to December 31st 2005.

Key exclusion criteria

none

Target sample size

1400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihito Kogure

Organization

National Organization Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

4-1-1, Sannnomaru, Naka-ku, Nagoya 460-0001 JAPAN

TEL

052-951-1111

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

Room 304, Namba Plaza Bldg. 3F 1-5-7,Motomachi Naniwa-ku, Osaka 556-0016, JAPAN

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

2008 Year 07 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed?term=23575412

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

Completed

Date of protocol fixation

2008 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date

2008 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Does gefitinib prolong the survival of adenocarcinoma patients against non -adeno non-small cell lung cancer? A retrospective study.


Management information

Registered date

2008 Year 07 Month 23 Day

Last modified on

2015 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001537


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name