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


Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name