UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006913
Receipt number R000008036
Scientific Title Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer
Date of disclosure of the study information 2011/12/20
Last modified on 2013/12/23 21:06:13

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Basic information

Public title

Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer

Acronym

Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer

Scientific Title

Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer

Scientific Title:Acronym

Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer

Region

Japan


Condition

Condition

Non-small Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To retrospectively evaluate how clinical backgrounds and treatment histories will affect survival time of patients in whom the administration of gefitinib was response

Basic objectives2

Efficacy

Basic objectives -Others


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

1.Patients who diagnosed with advanced non-small cell lung cancer (NSCLC) and administered gefitinib until October 2010

2.Stage IIIB/IV at the time of diagnosis

3.Performance status (PS) 0-2 at the time of diagnosis

4.Patients who responded to gefitinib with PR or CR assessed in daily clinical practice

Key exclusion criteria

1.patients with curative surgical operation

2.patients with curative radiation therapy

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumio Imamura

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Respiratory Medicine

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka

TEL

06-6972-1181

Email



Public contact

Name of contact person

1st name
Middle name
Last name Fumio Imamura

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Respiratory Medicine

Zip code


Address

1-3-3 Nakamichi,Higashinari-ku, Osaka

TEL

06-6972-1181

Homepage URL


Email

imamura-fu@mc.pref.osaka.jp


Sponsor or person

Institute

Kansai Respiratory Clinical Network Research Group

Institute

Department

Personal name



Funding Source

Organization

Astrazeneca

Organization

Division

Category of Funding Organization

Profit organization

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 12 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.journals.elsevier.com/lung-cancer/

Number of participants that the trial has enrolled


Results

A total of 335 patients were recruited. Twenty-eight (8.4%) patients survived more than 5 years.Sixty-five and 93 patients received gefitinib as rechallenge and beyond progressive disease (BPD), respec-tively. A statistically significant difference in OS was observed between the patients who underwentgefitinib rechallenge and those who did not rechallenge (median: 1272 days vs. 774 days; p < 0.001), aresult supported by a DTRA. Patients treated with gefitinib BPD also showed a tendency of longer survival.Conclusions: Gefitinib rechallenge and BPD played a central role in long term survival of the patients whoinitially responded to gefitinib.

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

2011 Year 11 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2012 Year 12 Month 31 Day

Date of closure to data entry

2013 Year 01 Month 31 Day

Date trial data considered complete

2013 Year 01 Month 31 Day

Date analysis concluded

2013 Year 01 Month 31 Day


Other

Other related information

After extracting information corresponding to the above items from the medical records of the subjects, a database will be created to summarize and analyze the information for retrospective evaluation. Attention must be paid not to extract personally identifiable information (name, medical record numbers, date of birth, etc.). The data will be anonymized at the time of submission to the representative research institution.


Management information

Registered date

2011 Year 12 Month 20 Day

Last modified on

2013 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008036


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name