UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006144 |
|---|---|
| Receipt number | R000007263 |
| Scientific Title | A Phase II Study of Gefitinib Monotherapy as First-Line Treatment for Elderly Patients with Stage IIIB /IV Adenocarcinoma of the Lung |
| Date of disclosure of the study information | 2011/08/12 |
| Last modified on | 2011/08/10 14:17:57 |
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Basic information
Public title
A Phase II Study of Gefitinib Monotherapy as First-Line Treatment for Elderly Patients with Stage IIIB /IV Adenocarcinoma of the Lung
Acronym
A Phase II Study of Gefitinib Monotherapy as First-Line Treatment for Elderly Patients with Stage IIIB /IV Adenocarcinoma of the Lung
Scientific Title
A Phase II Study of Gefitinib Monotherapy as First-Line Treatment for Elderly Patients with Stage IIIB /IV Adenocarcinoma of the Lung
Scientific Title:Acronym
A Phase II Study of Gefitinib Monotherapy as First-Line Treatment for Elderly Patients with Stage IIIB /IV Adenocarcinoma of the Lung
Region
| Japan |
Condition
Condition
Adenocarcinoma of the lung
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of gefitinib as first-line therapy in elderly patients with advanced adenocarcinoma of the lung.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Disease control rate, median survival time, 1-year survival rate, progression-free survival time and adverse events
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
Gefitinib treatment
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) Histologically or cytologically proven adenocarcinoma of the lung
2) Chemotherapy-naive patients
3) Stage IIIB, not candidate for curative radiotherapy or stage IV including recurrence disease after surgery
4) Aged 70 years or older
5) Measurable disease
6) ECOG performance status of 0-2
7) Adequate organ function
8) Written informed consent
Key exclusion criteria
1) Concomitant serious medical conditions
2) Interstitial lung disease or pulmonary fibrosis detected by conventional computed tomography of the chest
3) Massive pleural or pericardial effusion or ascites that required drainage, superior vena caval syndrome or symptomatic brain metastasis
4) History of serious drug allergy
5) Previous radiotherapy to the primary tumor
6) Other concurrent active malignancy
7) Pregnancy or lactation
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, JAPAN
TEL
0564-21-6251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, JAPAN
TEL
0564-21-6251
Homepage URL
hsaito@acc-aichi.com
Sponsor or person
Institute
Central Japan Lung Study Group
Institute
Department
Personal name
Funding Source
Organization
Central Japan Lung Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
愛知県がんセンター愛知病院（愛知県）
名古屋大学附属病院（愛知県）
名古屋第二赤十字病院（愛知県）
公立陶生病院（愛知県）
名古屋掖済会病院（愛知県）
豊橋市民病院（愛知県）
トヨタ記念病院（愛知県）
JA愛知厚生連加茂病院（愛知県）
NHO東名古屋病院（愛知県）
大垣市民病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | 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
Completed
Date of protocol fixation
| 2004 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 10 | Day |
Last modified on
| 2011 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007263
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
