UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004807 |
|---|---|
| Receipt number | R000005724 |
| Scientific Title | Phase I/II study of Gefitnib monotherapy as neo-adjuvant chemotherapy for cN2 lung adenocarcinoma with the EGFR mutation |
| Date of disclosure of the study information | 2010/12/29 |
| Last modified on | 2012/04/19 14:11:53 |
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Basic information
Public title
Phase I/II study of Gefitnib monotherapy as neo-adjuvant chemotherapy for cN2 lung adenocarcinoma with the EGFR mutation
Acronym
Phase I/II study of Gefitnib monotherapy as neo-adjuvant chemotherapy for cN2 lung adenocarcinoma with the EGFR mutation
Scientific Title
Phase I/II study of Gefitnib monotherapy as neo-adjuvant chemotherapy for cN2 lung adenocarcinoma with the EGFR mutation
Scientific Title:Acronym
Phase I/II study of Gefitnib monotherapy as neo-adjuvant chemotherapy for cN2 lung adenocarcinoma with the EGFR mutation
Region
| Japan |
Condition
Condition
lung adenocarcinoma
Classification by specialty
| Surgery in general | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety for the treatment of gefitinib monotherapy in neo-adjuvant chemotherapy with cT1-3N2M0 (cStage IIIA) of non-small cell lung cancer with EGFR mutation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of completion and complications of the protocol treatment
Key secondary outcomes
Rate of response, completion, and complications of neo-adjuvant chemotherapy
Rate of complete resection and complications of operation
3-year overall survival
disease free survival
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
gefitinib 250mg/body/day 8weeks
surgery
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically or cytologically confirmed adenocarcinoma
(2) resectable with cT1-3N2M0 lung cancer
(3) Patients with EGFR mutation (Eexon19 deletion, L858R, L861Q, G719A, G719C, G719S) which is expected the good response with gefitinib
(4) Patients who have not previously treated yet
(5) ECOG PS 0-1
(6) Sufficient organ functions
white blood cell count >=3000/uL
platelet count >=100000/uL
hemoglobin >= 8.0 g/dl
GOT and GPT <= 2.0x upper normal limit
serum bilirubin level <= 1.5 mg/dl
serum creatinine level <= 1.5 mg/dl
PaO2 >= 70 mmHg
(7) life expectancy more than 3 month
(8) Provided written informed consent
Key exclusion criteria
(1) patients who has interstitial pneumonia identified by chest CT or by blood test
(2)
(3) Patients with EGFR mutation (T790M) which is NOT expected the good response with gefitinib.
(4) Patients with uncontrollable complications
(5) Pregnant or lactation women, or women with known or suspected pregnancy
(6) Patients with severe malabsorption syndrome or with severe functional gastrointestinal disorder
(7) patients with systemic administration steroids over 4 weeks
(8) Patients with contraindication of gefitinib
(9) Patients with active concomitant malignancy
(10) Inappropriate patients for this study judged by the physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yotaro Izumi |
Organization
Keio University School of Medicine
Division name
division of General Thoracic Surgery
Zip code
Address
35 shinanomachi, shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
division of General Thoracic Surgery
Zip code
Address
35 shinanomachi, shinjuku-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
KantoKoshinetsu lung cancer research group
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine, division of General Thoracic Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KantoKoshinetsu lung cancer research group
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
慶應義塾大学病院
埼玉医科大学総合医療センター
埼玉医科大学国際医療センター
独協医科大学病院
帝京大学病院
大阪大学病院
新潟県立がんセンター新潟病院
埼玉県立呼吸器循環器病センター
東京女子医科大学病院
都立駒込病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 29 | 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
| 2010 | Year | 12 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 29 | Day |
Last modified on
| 2012 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005724
