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 2013/12/29 14:50:42

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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
Middle name
Last name Shinji Kikuchi

Organization

Tsukuba University Hospital

Division name

Department of Thoracic Surgery

Zip code


Address

1-1-1 Tennodai,Tsukuba 305-8575 Japan

TEL

029-853-5600(90169)

Email

S.kikuchi@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinji Kikuchi

Organization

Tsukuba University Hospital

Division name

Department of Thoracic Surgery

Zip code


Address

1-1-1 Tennodai,Tsukuba 305-8575 Japan

TEL

029-853-5600(90169)

Homepage URL


Email

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


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



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


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

2013 Year 12 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 02 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

2013 Year 12 Month 29 Day

Last modified on

2013 Year 12 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014866


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name