UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012725 |
|---|---|
| Receipt number | R000014866 |
| Scientific Title | Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations |
| Date of disclosure of the study information | 2014/01/02 |
| Last modified on | 2025/01/06 14:26:53 |
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Basic information
Public title
Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Acronym
Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Scientific Title
Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Scientific Title:Acronym
Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Surgery in general | Chest surgery | Radiology |
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Radical resection 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 | Maneuver |
Interventions/Control_1
Patients will receive daily erlotinib at 150mg/day for six weeks. The patients with responsive disease considered to be technically resectable will undergo surgical resection.
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
1) Histologically or cytologically proven non-small cell lung cancer
2) cStageIII-N2
3) Activating EGFR mutations
4) Without previously treatment for lung cancer
5) Has measurable by RECIST (ver. 1.1) criteria
6) ECOG performance status 0-1
7) Age >= 20 years
8) Adequate organ function
Absolute neutrophil count (ANC) >= 1,500/mm3
Platelets >= 100000/mm3
Hemoglobin >= 9.0g/dL
AST and ALT <= 2.5 x ULN
Total bilirubin <= 1.5 x ULN
Serum creatinine <= 1.5 x ULN
SpO2 >= 90%
9) Life expectancy more than 3 months
10) Signed written informed consent
Key exclusion criteria
1) Active lung disease such as interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or medicine-induced pneumonitis
2) Prior exposure to agents directed at the HER axis (e.g. erlotinib, gefetinib, cetuximab, trastuzumab)
3) Gastrointestinal abnormalities, including active peptic ulcer or inflammatory bowel disease
4) Active ophthalmologic diseases (e.g. Sjogrens)
5) Neurological symptoms of spinal cord compression
6) Uncontrolled infections
7) History of severe heart disease
8) Serious medical complications
9) Multiple primary cancer
10) Serious psychiatric illness or psychological symptom
11) Women who are pregnant, lactating or with childbearing potential
12) Ineligible based on decision of an investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Kikuchi |
Organization
Tsukuba University Hospital
Division name
Department of Thoracic Surgery
Zip code
305-8575
Address
1-1-1 Tennodai,Tsukuba 305-8575 Japan
TEL
029-853-5600(90169)
S.kikuchi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Kikuchi |
Organization
Tsukuba University Hospital
Division name
Department of Thoracic Surgery
Zip code
305-8575
Address
1-1-1 Tennodai,Tsukuba 305-8575 Japan
TEL
029-853-5600(90169)
Homepage URL
S.kikuchi@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Tsukuba University Hospital
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
none
Address
none
Tel
none
none
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
| 2014 | Year | 01 | Month | 02 | 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
1
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2040 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014866
