UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000136
Receipt number R000000202
Scientific Title phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.
Date of disclosure of the study information 2005/09/08
Last modified on 2016/09/27 16:32:26

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Basic information

Public title

phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.

Acronym

phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.

Scientific Title

phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.

Scientific Title:Acronym

phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.

Region

Japan


Condition

Condition

lung adenocarcinoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the efficacy and safety of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Primary endpoint: response rate. Secondary endpoints: disease control rate, overall survival, time to progression, and toxicity.

Key secondary outcomes



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

Medicine

Interventions/Control_1

Patients receive oral 250-mg gefitinib daily until disease progression.

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) primary lung adenocarcinoma; 2) stage IIIB or IV disease, unsuitable for radical thoracic radiation; 3) age of 70 years or older; 4) Eastern Cooperative Oncology Group performance status of 0 to 2; 5) no prior chemotherapy; 6) measurable lesions; 7) adequate organ fanctions; and 8) written informed consent.

Key exclusion criteria

1) interstitial pneumonitis or pulmonary fibrosis; 2) thoracic radiation within four weeks; 3) ongoing or planning palliative radiation; 4) symptomatic brain metastases; 5) uncontrolled pleural effusion; 6) pericardial effusion requiring drainage; 7) watery diarrhea; 8) serious underlying disease; 9) active concomitant malignancies; 10) a history of serious drug allergy; 11) clinically significant psychiatric disorder; and 12) unsuitable for entry to the study, decided by a medical oncologist.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaoru Matsui (head), Masashi Kobayashi (secretariat)

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Division name

Department of Thoracic Malignancy

Zip code


Address

3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan

TEL

0729-57-2121

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masashi Kobayashi (secretariat)

Organization

Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

Division name

Department of Thoracic Malignancy

Zip code


Address

3-7-1 Habikino, Habikino-shi, Osaka 583-8588, Japan

TEL

0729-57-2121

Homepage URL


Email



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 08 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=21715363

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

2004 Year 11 Month 29 Day

Date of IRB


Anticipated trial start date

2004 Year 12 Month 01 Day

Last follow-up date

2007 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 08 Day

Last modified on

2016 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000202


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name