UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000118 |
|---|---|
| Receipt number | R000000173 |
| Scientific Title | A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer |
| Date of disclosure of the study information | 2005/09/06 |
| Last modified on | 2005/09/06 13:20:36 |
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Basic information
Public title
A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Acronym
A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Scientific Title
A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Scientific Title:Acronym
A Phase II Trial of Gefitinib Monotherapy in Elderly Chemo-naïve Patients with Advanced Non–Small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety and efficacy of gefitinib monotherapy in elderly chemo-naïve patients with advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Gefinitib daily administration
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Histologically or cytologically confirmed NSCLC
Stage IIIB/IV
No prior treatment
Measurable disease
ECOG PS 0-2
Adequate organ function
Age ≥75
Written informed consent
Key exclusion criteria
Past history of drug hypersensitivity
SVC syndrome
Pleural or pericardial effusion that required drainage
Active infection
Interstitial pneumonia or active lung fibrosis
Symptomatic brain metastasis
Active concomitant malignancy
Uncontrolled diabetes
Uncontrolled heart disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Ebi |
Organization
Iizuka Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
3-83 Yoshio-machi, Iizuka city, Fukuoka, Japan Zip-code 820-8505
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
LOGIK
Division name
LOGIK
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
LOGIK
Institute
Department
Personal name
Funding Source
Organization
LOGIK
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 | 06 | 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
| 2004 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 05 | 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 | 06 | Day |
Last modified on
| 2005 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000173
