UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002811 |
|---|---|
| Receipt number | R000003423 |
| Scientific Title | Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2014/12/01 09:35:02 |
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Basic information
Public title
Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Acronym
Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Scientific Title
Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Scientific Title:Acronym
Clinical relevance and biomarker search of erlotinib against chemotherapy-treated recurrent non-small cell lung cancer
Region
| Japan |
Condition
Condition
Chemotherapy-treated recurrent non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical relevance of erlotinib for patients with chemotherapy-treated recurrent non-small cell lung cancer according to EGFR mutation status, and to search biomarkers for predicting erlotinib effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate at week 8.
Key secondary outcomes
Response rate, waterfall plot analysis, progression free survival time, overall survival time, safety, biomarker analysis, detection of EGFR mutation in blood sample
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
Erlotinib 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with all of the following conditions;
1) Non-small cell lung cancer proven by histology and/or cytology
2) Recurrent non-small cell lung cancer already treated with 1 or 2 regimen, excluding post-operative adjuvant chemotherapy
3) Tissue sampling available for biomarker search/analysis
4) Age equal or older than 20-y at enrollment
5) No prior treatment with EGFR-TKIs
6) Able to be treated with PO medication
7) Measurable lesion by RECIST
8) PS of 0, 1 or 2
9) Able to be intensely monitored at least for 2 weeks
10) Adequate organ functions, evaluated within 2 weeks before enrollment, as;
a) WBC >= 3,000/mm3
b) Netrophile >= 1,500/mm3
c) Hb >= 9.0 g/dL
d) Plt >= 100,000/mm3
e) AST/ALT <= 100 IU/L
f) T. Bil <= 1.5 g/dL
g) Serum creatinine <= 1.5 mg/dL
h) SpO2 >= 90%
11) Life expectancy of more than 3 months
12) Interval from previous treatment, of following, at enrollment;
a) Equal or more than 3 weeks after completion of previous chemotherapy
b) Equal or more than 4 weeks after completion of thoracic irradiation
c) Equal or more than 1 week after completion of irradiation except for thoracic irradiation
d) Equal or more than 2 weeks after surgical intervention including pleurodesis and pleural drainage
13) Witten informed consent from the patient
Key exclusion criteria
Patients with at least one of the following conditions are ineligible
1) Patients with idiopathic pulmonary fibrosis, other interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, drug induced pulmonary damage
2) Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage
3) Patients with infection requiring iv administration of antibiotics and/or antifungal agents
4) Patients unable to be treated with PO drugs
5) Clinically significant eye diseases such as severe dry eye, keratoconjunctivitis
6) Pregnancy, breast feeding and suspected pregnancy
7) Symptomatic brain metastasis
8) Active synchronous malignancies
9) Uncontrolled diabetes mellitus
10) Other clinically significant complications
11) Other conditions inadequate for this research
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takiguchi, Yuichi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology/Division of Clinical Oncology
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2577
takiguchi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takiguchi, Yuichi |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology/Division of Clinical Oncology
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2577
Homepage URL
takiguchi@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Respirology/Division of Clinical Oncology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Respirology/Division of Clinical Oncology, Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Chiba Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
G21031
Org. issuing International ID_1
Clinical study review board at Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学（千葉県）、千葉県がんセンター（千葉県）、その他交渉中
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 29 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003423
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