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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005086
Receipt No. R000006047
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
Date of disclosure of the study information 2011/02/15
Last modified on 2018/03/20

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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
Middle name
Last name Yukito Ichinose
Organization National Hospital, Kyushu Cancer Center
Division name Institute for Clinical Research
Zip code
Address 3-1-1 Notame, Minami-ku, Fukuoka, 811-1395,japan
TEL 092-541-3231
Email yichinos@nk-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sho Saeki
Organization Kumamoto University hospital
Division name Department of Respiratory Medicine
Zip code
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
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 飯塚病院(福岡県)
北九州市立医療センター(福岡県)
JCHO九州病院(福岡県)
九州大学(福岡県)
久留米大学(福岡県)
国立病院機構九州医療センター(福岡県)
国立病院機構九州がんセンター(福岡県)
国立病院機構福岡東医療センター(福岡県)
済生会福岡総合病院(福岡県)
製鉄記念八幡病院(福岡県)
福岡大学(福岡県)
大分大学(大分県)
大分県立病院(大分県)
熊本大学(熊本県)
佐賀大学(佐賀県)
JCHO諫早総合病院(長崎県)
長崎大学(長崎県)
日本赤十字社長崎原爆病院(長崎県)
宮崎県立宮崎病院(宮崎県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
岡山大学病院(岡山県)
呉共済病院(広島県)
中国中央病院(広島県)
山口宇部医療センター(山口県)
四国がんセンター(愛媛県)
国立病院機構岩国医療センター(山口県)
尾道市立市民病院(広島県)
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)
神戸赤十字病院(兵庫県)
岡山労災病院(岡山県)
福山医療センター(広島県)
群馬大学大学院医学系研究科(群馬県)
都立駒込病院(東京都)
岡山済生会総合病院(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 No longer recruiting
Date of protocol fixation
2010 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2022 Year 01 Month 31 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
2018 Year 03 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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