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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026197
Receipt No. R000030067
Scientific Title A phase II trial of induction erlotinib followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.
Date of disclosure of the study information 2017/02/17
Last modified on 2017/06/01

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Basic information
Public title A phase II trial of induction erlotinib followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.
Acronym Personalized Induction Therapy Clinical Trial-3 (PIT-3)
Scientific Title A phase II trial of induction erlotinib followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.
Scientific Title:Acronym Personalized Induction Therapy Clinical Trial-3 (PIT-3)
Region
Japan

Condition
Condition Stage IIIA-N2 EGFR mutated, Non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the saftey and efficacy of erlotinib followed by surgical resection for patients with pathologically confirmed stage IIIA-N2 EGFR mutated non-small cell lung cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year progression-free survival
Key secondary outcomes 5-year progression-free survival
2-year and 5-year overall survival
Completion rate of the protocol treatment
Complete resection rate
Radiological response rate
Down staging rate
Safety
Pathological response (Ef)
Tumor markers (CEA/CYFRA)
SUVmax on FDG-PET scan

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 The surgical resection is performed after 8 weeks of oral administration of erlotinib (150mg/day).
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Histologically or cytologically proven EGFR mutated (Ex19 deletions or Ex21 L858R) non-small cell lung cancer diagnosed using specimen material obtained from primary tumor or metastastatic lymph node
(2) Stage IIIA- pathologically proven N2 disease
(3) Without previously treatment for lung cancer
(4) Age >=20
(5) ECOG PS 0-1
(6) Expected FEV 1.0 > 800ml after lung resection
(7) Adequate organ function
(8) Written informed consent
Key exclusion criteria (1) EGFR mutation T790M postive
(2) Interstitial pneumonia or pulmanary fibrosis detectable on chest CT scan
(3) Privious history of drug induced lung injury
(4) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.)
(5) Aactive infection
(6) History of congestive heart failure, angina pectoris or myocardial infarction withinthe last 1 year.
(7) Unterated bone fracture or serious wound
(8) Severe diarrhea
(9) Current or previous (within the last 1 year) history of GI perforation or diverticultis
(10) Ireus
(11) Severe drug allergy
(12) Investigational new drug or the unapproved drug is administered
(13) History of active double cancer
(14) History of pregnancy or lactation
(15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morihito Okada
Organization Hiroshima University
Division name Thoracic Surgery
Zip code
Address 1-2-3 kasumi minami-ku Hiroshima,Hiroshima
TEL 082-257-5869
Email morihito1217@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Takamochi
Organization Juntendo University
Division name Thoracic Surgery
Zip code
Address 3-1-3 Hongo Bunkyo-ku,Tokyo
TEL 03-3813-3111
Homepage URL
Email ktakamo@juntendo.ac.jp

Sponsor
Institute Advanced Clinical Trial chest surgery Group (ACTG)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 順天堂大学(東京都)
広島大学(広島)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 17 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
2016 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2025 Year 02 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 17 Day
Last modified on
2017 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030067


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