UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001863 |
|---|---|
| Receipt number | R000002239 |
| Scientific Title | A Phase II study of Gefitinib as First-Line Treatment for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations. |
| Date of disclosure of the study information | 2009/04/08 |
| Last modified on | 2015/10/28 14:09:15 |
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Basic information
Public title
A Phase II study of Gefitinib as First-Line Treatment for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations.
Acronym
First-Line Gefitinib for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations.
Scientific Title
A Phase II study of Gefitinib as First-Line Treatment for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations.
Scientific Title:Acronym
First-Line Gefitinib for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations.
Region
| Japan |
Condition
Condition
Non-Small-Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and feasibility of gefitinib as first-line treatment for elderly patients with non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations.
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, Quality of life, 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) Chemotherapy-naive patients with non-small-cell lung cancer
2) Stage IIIB or IV
3) Patients having EGFR mutation (exon 19 deletion or L858R)
4) Patients aged 70 years or older
5) Measurable lesion
6) ECOG performance status 0 to 2
7) Adequate organ function
8) Written informed consent
Key exclusion criteria
1) Active infection, uncontrolled heart disease or diabetes mellitus
2) Interstitial pneumonia / pulmonary fibrosis on computed tomography scan
3) Massive pleural or pericardial effusion, or ascites
4) Superior vena cava syndrome
5) Symptomatic brain metastases
6) Severe drug allergy
7) Previous radiotherapy to the primary tumor
8) Postoperative adjuvant therapy
9) Other concurrent active malignancy
10) Pregnant or breast-feeding woman
Target sample size
19
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 | Kosuke Takahashi |
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
Sponsor or person
Institute
Central Japan Lung Study 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
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
| 2009 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 08 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002239
