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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000187
Receipt No. R000000182
Scientific Title A phase II study of gefitinib in PS3 (4) advanced adenocarcinoma of the lung
Date of disclosure of the study information 2005/09/12
Last modified on 2005/09/08

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Basic information
Public title A phase II study of gefitinib in PS3 (4) advanced adenocarcinoma of the lung
Acronym Poor PS:Gefitinib
Scientific Title A phase II study of gefitinib in PS3 (4) advanced adenocarcinoma of the lung
Scientific Title:Acronym Poor PS:Gefitinib
Region
Japan

Condition
Condition PS 3 patients (or PS 4 patients because of bone or brain metastasis) with advanced adenocarcinoma of the lung.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effect and toxicity profile of gefitinib in PS 3 patients (or PS 4 patients because of bone or brain metastasis) with advanced adenocarcinoma of the lung.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall response rate
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 The treatment schedule included gefitinib at 250mg/day, administered once daily.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with histologic or cytologic confirmation of adenocarcinoma of the lung regardless of previous chemotherapy were eligible.
The eligibility criteria were as follows; (1) measurable lesions; (2) age ≥ 20, (3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3 (4; because of bone or brain metastasis) (4) adequate organ function
Key exclusion criteria The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with apparent abnormalities on chest X-ray, acute inflammation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, severe heart disease, uncontrollable diabetes mellitus, severe infection.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayasu Kurata
Organization Hyogo Medical Center for Adults
Division name Department of Medical Oncology
Zip code
Address 13-70, Kitaoji-cho, Akashi City, Hyogo, Japan, 673-8558
TEL 078-929-1151
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2,Onohigasi,Osakasayama City,Osaka,Jupan
TEL 072-366-0221
Homepage URL
Email

Sponsor
Institute Department of Medical Oncology,
Kinki University School of Medicine
Institute
Department

Funding Source
Organization Department of Medical Oncology,
Kinki University School of Medicine
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 12 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
Date of protocol fixation
2003 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2003 Year 07 Month 01 Day
Last follow-up date
2006 Year 07 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 12 Day
Last modified on
2005 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000182

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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