UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000187 |
|---|---|
| Receipt number | 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 11:16:15 |
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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
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
Sponsor or person
Institute
Department of Medical Oncology,
Kinki University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000182
