UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003539 |
|---|---|
| Receipt number | R000004221 |
| Scientific Title | Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC |
| Date of disclosure of the study information | 2010/04/30 |
| Last modified on | 2014/12/03 16:11:30 |
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Basic information
Public title
Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC
Acronym
Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC
Scientific Title
Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC
Scientific Title:Acronym
Phase II study to investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate efficacy and safety of erlotinib in elderly patients with advanced and recurrent NSCLC who previously treated with chemotherapy
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, progression free survival, overall survival, safety profile
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
Single agent chemotherapy with Erlotinib.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Histologically or cytologically proven non-small cell lung cancer.
(2) Patients with recurrent non-small cell lung cancer of stage IIIB or IV after surgery who did not respond to or relapsed after prior >=2 chemothrepies.
(3) Patients aged 75 years or older.
(4) No prior treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI)
(5) Patient who has at least one or more measurable lesion by RECIST.
(6) ECOG performance status (PS): 0-1
(7) Patients who are able to receive treatment by hospitalization for at least 2 weeks or under equivalent condition
(8) Sufficient function of main organs and bone marrow filled the following criteria.
- Leukocyte count >=3000/mm3
- Neutrophil count >=1500/mm3
- Hemoglobin >=8.0g/dL
- Platelet <=100,000/mm3
- AST and ALT <=100 IU/L
- Total bilirubin <=1.5mg/dL
- Serum creatinine <=1.5mg/dL
- Sp O2 >=90%
(9) Patients who are considered to survive for more than 3 months
(10) Time from the previous treatment at the time of day 1 of the study treatment.
Chemotherapy
- >=3 weeks from the last treatment
Radiation therapy
- Irradiation to chest: >=12 weeks from the last irradiation
- Irradiation to other lesion: >=2 weeks from the last irradiation
Surgery and treatment (pleural adhesion surgery and pleural drainage)
- >=2 weeks from the surgery/last treatment
(11) Patient who signed a written informed consent
Key exclusion criteria
(1) Patients with pulmonary disorders including idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia and drug-induced pneumonia
(2) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome
(3)Patients with complication with infectious disease which requires intravenous injection of antibiotic or antimycotic agent
(4) Patients who have been treated with HER drugs (gefitinib, trastuzumab, lapatinib, cetuximab)
(5) Patients who are not able to take oral medication
(6) Patients with clinically significant ophthalmologic disorder (severe eye disorders including Sjogren's syndrome, keratoconjunctivitis sicca, keratitis)
(7) Pregnant or lactating women
(8) Brain metastasis with symptoms
(9) Active multiple cancer
(10) Diabetes patients with poor disease control
(11) Patients with clinically significant complications (including cardiac disorder with poor control, severe arrhythmia requires medication, persistent watery diarrhea)
(12) Patients who are considered ineligible based on decision of a responsible investigator
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ueoka |
Organization
National Hospital Organization,Yamaguchi - Ube Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
685 Higashikiwa, Ube-City, Yamaguchi, 755-0241, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Segawa |
Organization
National Hospital Organization,Yamaguchi - Ube Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
685 Higashikiwa, Ube-City, Yamaguchi, 755-0241, Japan
TEL
0836-58-2300
Homepage URL
Sponsor or person
Institute
Yamaguchi Thoracic Oncology Group(YTOG)
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
専門病院・医院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | 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
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2014 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004221
