UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026197 |
|---|---|
| Receipt number | 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 16:58:16 |
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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
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
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
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
ktakamo@juntendo.ac.jp
Sponsor or person
Institute
Advanced Clinical Trial chest surgery Group (ACTG)
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030067
