UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation
Acronym	Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation
Scientific Title	Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation
Scientific Title:Acronym	Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutation
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Step 1: confirmation of safety of induction gefitinib followed by cisplatin and docetaxel with concurrent thoracic radiotherapy in loclly advanced non-small cell lung cancer with EGFR mutation Step 2: evaluation of efficacy and safety of induction gefitinib followed by cisplatin and docetaxel with concurrent thoracic radiotherapy in loclly advanced non-small cell lung cancer with EGFR mutation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Two year survival rate
Key secondary outcomes	Survival time, progression free survival time, five year survival rate, completion rate of protocol therapy, response rate of induction therapy, response rate of chemoradiation, site and type of progression, incidence of adverse events, correlation between radiation field and survival, correlation between protein expression of molecular marker; ERCC1, RRM1, BRCA1, TSP1, TXR1, thioredoxin, and efficacy or safety

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	Induction therapy with gefitinib Cisplatin and docetaxel with concurrent thoracic radiotherapy
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) Non small-cell lung cancer proven cytologically or histologically 2) Patients having EGFR mutation (exon 19 deletion or L858R) 3) treatment naive c-stage IIIA or IIIB 4) Patient who has measurable lesion by RECIST. 5) V20 in radiation field <= 35% 6) oral intake possible 7) Performance status (ECOG)0-2. 8) age 20-74 years old 9) adequate organ functions(within 2 weeks before registration) 1. WBC >= 3,500/mm3 2. Neu >= 2,000/ mm3 3. Plt >= 100,000/ mm3 4. Hb >= 9.0g/dl 5. AST and ALT, x 2 of upper limit of normal (ULN) or less 6. T-Bil < 1.5mg/dl 7. Serum creatinin, x 1.5 of ULN or less creatinine clearance>=60ml/min 8. SpO2 or blood gas SpO2 >= 90% or PaO2 >= 60 torr 9. Lung function 1 second amount More than 1.5L 10) Written informed consent
Key exclusion criteria	1) Patients having EGFR gene mutation (T790M) 2) Past history of drug hypersensitivity 3) Patients with superior vena cava (SVC) syndrome 4) pulmonary fibrosis or interstitial pneumonitis evident on chest CT 5) serious heart dosease 6) Psychiatric disorder 7) uncontrollable diabetes 8) paresis of intestine, intestinal obstruction 9) Patients with active severe infections 10) serious complications other 11) Patients with active concomitant malignancy 12) Pregnant or lactation women, or women with known or suspected pregnancy 13) Inappropriate to entry by physician
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Katsuyuki Middle name Last name Hotta
Organization	Okayama University Hospital
Division name	Center for Innovative Clinical Medicine
Zip code	700-8558
Address	2-5-1 Shikata-cho,kita-ku, Okayama
TEL	086-223-7151
Email	khotta@okayama-u.ac.jp

Public contact
Name of contact person	1st name Sho Middle name Last name Saeki
Organization	Kumamoto University hospital
Division name	Department of Respiratory Medicine
Zip code	860-8556
Address	1-1-1 Honjo, Kumamoto-city,Kumamoto,860-8556,Japan
TEL	096-373-5012
Homepage URL
Email	saeshow@wg7.so-net.ne.jp

Sponsor
Institute	Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Okayama Lung Cancer Study Group (OLCSG)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Network Fukuoka Certified Review Board
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel	092-643-7171
Email	mail@crnfukuoka.jp

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	北九州市立医療センター（福岡県） 九州大学病院（福岡県） 国立病院機構九州がんセンター（福岡県） 熊本大学病院（熊本県） 岡山大学病院（岡山県） 中国中央病院（広島県） 四国がんセンター（愛媛県） 愛媛県立中央病院（愛媛県） 日本赤十字社岡山赤十字病院（岡山県）

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 15 Day

Related information
URL releasing protocol	http://www.logik.jp/
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	Main results already published
Date of protocol fixation	2010 Year 12 Month 04 Day
Date of IRB	2011 Year 02 Month 07 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 02 Month 15 Day
Last modified on	2022 Year 04 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006047